regulatory affairs executive Jobs in Istanbul

regulatory affairs executive

regulatory affairs manager Jobs in Istanbul

regulatory affairs manager

administrative affairs manager Jobs in Istanbul

administrative affairs manager

assistant compliance officer Jobs in Istanbul

assistant compliance officer

compliance agent (legal account restriction) Jobs in Istanbul

compliance agent (legal account restriction)

regulatory compliance manager

AbbVie

<div><b>Company Description</b><p><br>
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas &ndash; immunology, oncology, neuroscience, and eye care &ndash; and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.</p><b><br>
Job Description</b><p><br>
Reports to: OEC Director - Region South, Italy &amp; Central Eastern Europe</p><p>
As the OEC leader in the local Affiliate you report through the AbbVie Office of Ethics &amp; Compliance Organization. You are responsible for providing leadership, direct oversight and enhancement of the Ethics &amp; Compliance Program in Turkey.</p><p>
As OEC Manager you will be a full member of the local Affiliate Management Team (AMT) in Turkey and as such you will actively contribute to the overall affiliate business &amp; talent strategy.</p><p>
The Compliance Manager supports AbbVie&rsquo;s internal auditing process by acting as the main point of contact for the audit team, preparing and conducting the audit as well as following up completion of potential observations. Provide strategic direction and leadership for the Affiliate.</p><p><b>
Highlighted Responsibilities
</b></p><ul><li>Create and maintain a best-in-class compliance program in partnership with the Affiliate Compliance Insights Forum (ACIF) to support AbbVie&rsquo;s business in Turkey.</li><li>
As OEC Manager you will lead the ACIF Meetings and ensure representativeness, effectiveness and alignment between all its members.</li><li>
Provides guidance and support in Turkey on national industry codes and regional/international industry codes (e.g., [Turkey code reference]. IFPMA and EFPIA Codes), government regulations on anti-corruption and other initiatives sponsored by the Office of Ethics &amp; Compliance.</li><li>
Act as a strategic partner to the business by providing ethics &amp; compliance guidance on proposed Affiliate programs, tactics, activities and strategies, identifies basic legal, regulatory or other relevant issues and refers matters to respective departments, analyses alternatives and proposes solutions to the business.</li><li>
Performs compliance risk assessments, trend analyses and provides and implements best practices recommendations.</li><li>
Detects, anticipates and prevents risks.</li><li>
Implements, manages and interprets compliance policies, procedures and practices.</li><li>
Contributes to the Global compliance program and OEC International Goals by developing, implementing and managing initiatives across multiple geographies.</li><li>
Develops, implements, and coordinates awareness, education and training programs that focus on the elements of the Code of Business Conduct, policies and procedures and applicable industry codes and regulations. Create and maintain effective lines of communication on compliance topics.</li><li>
Ensures ethics and compliance records, documents and databases are organized, completed and maintained.</li><li>
Is an active member of the Medical-Legal-OEC-Regulatory (MLOR) meetings of the Turkish Affiliate.</li><li>
Participates in local Industry group meetings, when applicable, shaping the external environment and identifying changes and trends, communicating them to the ACIF and the OEC Area &amp; International Leadership, and implementing necessary changes in the Affiliate Compliance Program.</li><li>
Develops, implements, modifies and oversees the execution of the Affiliate monitoring plan to ensure compliance with policies and procedures.</li><li>
In consultation with Legal where applicable, and working with ACIF, ensure any country-specific externally mandated anti-bribery/anti-corruption systems (co-ordination, governance, process) are implemented and functioning as required. Examples include contributing to the creation of the model itself, coordinating the Affiliate Audit Team (internal or external) by defining the Audit Plan, Sample Methodology, analysis of any observations, and definition of the corrective and preventive measures.</li></ul><br>
<b>
Qualifications</b><br>
<ul><li>
Bachelor&rsquo;s degree required.</li><li>
Equivalent work experience from Finance, Audit, Commercial, Legal or Regulatory strongly preferred.</li><li>
Professional experience in Compliance, and exposure to functions such as Legal, Regulatory, Finance or Government Affairs.</li><li>
Pharmaceutical and Global industry experience preferred.</li><li>
Possesses a deep understanding of the business and environment.</li><li>
Has a learning mindset, digs deep for insights to guide actions and routinely measures to determine impact.</li><li>
Sets clear direction, prioritizes effectively and can make informed choices that drive impact. Has the ability to balance strategic thinking with tactical execution of the Compliance program and easily switch between both.</li><li>
Can influence decisions as a fully integrated member of the cross-functional team, both on-site and remotely as necessary.</li><li>
Can effectively and continuously identify, monitor, enhance, sustain and update OEC Policies, Procedures and Trainings.</li><li>
Acts wisely under pressure and is self-assured in representing the team, function or organization.</li><li>
Strong verbal and written communication, including fluent command of English.</li></ul><br>
<b>
Additional Information</b><div></div><p><br>
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.</p><p>
US &amp; Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html</p><p>
US &amp; Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:</p><p>
https://www.abbvie.com/join-us/reasonable-accommodations.html</p></div>

OEC (Office of Ethics & Compliance) Manager – Turkey

Gilead Sciences

<div><div>At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.</div><div><br>
Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.</div><div><br>
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.<br>
<br>
Job Description</div><div><br>
Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.</div><div></div><div>
Knowledge &amp; Details:</div><ul><li><div>
Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.</div></li><li><div>
Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.</div></li><li><div>
Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.</div></li><li><div>
Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.</div></li><li><div>
Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.</div></li><li><div>
Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.</div></li><li><div>
Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.</div></li><li><div>
Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.</div></li><li><div>
Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.</div></li><li><div>
Actively contribute to local and global initiatives that improve regulatory processes.</div></li></ul><div></div><div>
Professional Experience / Key Skills</div><ul><li><div>
Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.</div></li><li><div>
Degree in Pharmaceutical Sciences or equivalent discipline is preferred.</div></li></ul><ul><li><div>
Proven ability to prioritize, conduct, and manage time to meet project deadlines.</div></li><li><div>
Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.</div></li><li><div>
Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.</div></li><li><div>
Strong focus on achievement of goals and continuous improvement</div></li><li><div>
Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.</div></li><li><div>
Having excellence in multiple project management, good communication and interpersonal skills.</div></li><li><div>
Be an analytical thinker, problem solver, proactive, initiative taker, creative personality</div></li><li><div>
Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.</div></li><li><div>
Fluency in spoken and written English.</div></li><li><div>
Good decision-making skills are important.</div></li><li><div>
Excellent verbal, written, organization skills and interpersonal communication skills required.</div></li></ul><div></div><div><br>
Equal Employment Opportunity (EEO)</div><div>
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively &quot;Gilead&quot; or the &quot;Company&quot;) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.</div><div></div><div><br>
For Current Gilead Employees and Contractors:</div><div>
Please apply via the Internal Career Opportunities portal in Workday.</div></div>

Regulatory Affairs Manager

<div>
 At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 <br/>
 <br/>
 Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 <br/>
 <br/>
 We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
 <br/>
 <br/>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.
 <br/>
 <br/>
 <strong>
  Knowledge &amp; Details
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
  </li>
  <li>
   Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.
  </li>
  <li>
   Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.
  </li>
  <li>
   Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.
  </li>
  <li>
   Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
  </li>
  <li>
   Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
  </li>
  <li>
   Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.
  </li>
  <li>
   Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
  </li>
  <li>
   Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
  </li>
  <li>
   Actively contribute to local and global initiatives that improve regulatory processes.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Professional Experience / Key Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
  </li>
  <li>
   Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
  </li>
  <li>
   Proven ability to prioritize, conduct, and manage time to meet project deadlines.
  </li>
  <li>
   Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
  </li>
  <li>
   Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
  </li>
  <li>
   Strong focus on achievement of goals and continuous improvement
  </li>
  <li>
   Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
  </li>
  <li>
   Having excellence in multiple project management, good communication and interpersonal skills.
  </li>
  <li>
   Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
  </li>
  <li>
   Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.
  </li>
  <li>
   Fluency in spoken and written English.
  </li>
  <li>
   Good decision-making skills are important.
  </li>
  <li>
   Excellent verbal, written, organization skills and interpersonal communication skills required.
   <br/>
   <br/>
  </li>
 </ul>
 Equal Employment Opportunity (EEO)
 <br/>
 <br/>
 It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
 <br/>
 <br/>
 <strong>
  For Current Gilead Employees And Contractors
  <br/>
  <br/>
 </strong>
 Please apply via the Internal Career Opportunities portal in Workday.
</div>


Hepsiburada (NASDAQ: HEPS)

<div>
 <p>
  At Hepsiburada, we are driven by our mission to improve people's lives by developing innovative products and services. Prioritizing customer satisfaction, we offer over 280 million products across more than 30 categories. Through our marketplace model, we bring together over 100,000 businesses. With T&uuml;rkiye&rsquo;s and the region's largest Smart Operations Center, industry-leading R&amp;D initiatives, and innovative solutions, we contribute significantly to the growth of the e-commerce ecosystem. For the past two years, we have proudly held the title of Turkey's most recommended e-commerce platform.
 </p>
 <p>
  <br/>
 </p>
 <p>
  Through our innovative services like HepsiJET, Hepsipay, HepsiLojistik, HepsiAd, and Hepsiburada Global, we create value for all our stakeholders. Committed to harnessing technology for social benefit, our &ldquo;Technology Empowerment for Women Entrepreneurs&rdquo; program has connected thousands of women entrepreneurs with e-commerce, supporting their growth. Our goal is to leverage digitalization and e-commerce to enable greater economic participation.
 </p>
 <p>
  With 25 years of experience driven by innovation and entrepreneurship, we proudly continue our journey as &ldquo;T&uuml;rkiye&rsquo;s Hepsiburada&rdquo; and the first and only Turkish company listed on NASDAQ, the world's leading technology exchange.
 </p>
 <p>
  <br/>
 </p>
 <p>
  For our colleagues, we offer a work environment that supports creating together and adding more meaning to our work. As a team full of opportunities, we are happy to develop, produce and succeed together.
 </p>
 <p>
  If you want to be part of a team that creates value for everyone and makes life easier through innovative products and services&mdash;and contribute to exciting success stories&mdash;the future starts here.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Hepsipay
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  Hepsipay, T&uuml;rkiye&rsquo;s leading payment solutions provider in both e-commerce and physical retail, delivers a fast, secure, and seamless shopping experience to a broad customer base of over 17 million users.
 </p>
 <p>
  With its secure card storage feature, Hepsipay enables customers to use their saved cards not only on the Hepsiburada platform but also across dozens of e-commerce sites and millions of physical retail locations. Beyond payments, Hepsipay offers its users access to exclusive campaigns and loyalty programs, providing additional value and convenience.
 </p>
 <p>
  Customers can instantly access all their saved cards via their digital wallet and top up their wallets using instant credit to complete purchases quickly and easily.
 </p>
 <p>
  Hepsipay also empowers business partners with one-click payment, installment solutions, and the ability to accept payments across both online and offline channels. By tapping into Hepsipay&rsquo;s rapidly growing customer network, business partners benefit from higher conversion rates and larger basket sizes&mdash;unlocking new growth opportunities.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Our Requirements:
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   University degree in engineering, finance, law, economics, business or a related discipline,
  </li>
  <li>
   Proven experience (at least 6-7 years) in any or several areas of Compliance, AML, KYC, Sanctions areas (Core Compliance-Regulatory Compliance will be an asset),
  </li>
  <li>
   Proven managerial experience in planning, managing, evaluating and reporting of Compliance &amp; Internal Control Department&rsquo;s duties and works,
  </li>
  <li>
   Having good knowledge and skills on Sanction and Transaction Monitoring systems,
  </li>
  <li>
   Having ability to prioritize work flows and ensure deadlines are met,
  </li>
  <li>
   Certificates will be an asset (ACAMS, ICA or equivalent ones),
  </li>
  <li>
   Good skill of usage of office programs (specifically Excel, Power Point) and presentation skills,
  </li>
  <li>
   Investigative approach and analytical thinking,
  </li>
  <li>
   Strong relationship management,
  </li>
  <li>
   Experience of managing conflicting workloads and priorities.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Your Responsibilities:
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Monitor and ensure compliance with applicable legal regulations in the e- commerce, finance &amp; payment industry. Manage the identification of legal requirements, development and updating of policies and procedures to ensure compliance,
  </li>
  <li>
   Establish an effective internal control system regarding Compliance related issues within the company and identify potential risks through risk assessments and take necessary measures to mitigate them,
  </li>
  <li>
   Organize training programs to ensure employees have knowledge of legal regulations. Conduct awareness campaigns to promote understanding and adherence to legal requirements, as well as company policies and procedures,
  </li>
  <li>
   Act as an advisor to support business on financial crime related matters,
  </li>
  <li>
   Responsible for core AML Activities; Transaction Filtering (Releasing alerts, conducting system enhancements), Transaction Monitoring (Releasing alerts, conducting system enhancements, knowledge on SAR process), KYC process (Leading the governance, checking KYC files, providing advisory service),
  </li>
  <li>
   Responsible for preparing reports as periodic basis daily, weekly, monthly and yearly,
  </li>
  <li>
   Responsible of communication with local authorities (ie. MASAK),
  </li>
  <li>
   Conduct compliance related controls and complete relevant reporting,
  </li>
  <li>
   Follow up local financial crime related regulatory changes and take necessary actions,
  </li>
  <li>
   Monitor and manage of internal control activities carried out by internal control staff.
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   "Bu ilan sebebiyle yapaca&gbreve;&inodot;n&inodot;z ba&scedil;vurular arac&inodot;l&inodot;&gbreve;&inodot;yla toplanacak ki&scedil;isel verileriniz veri sorumlusu D-Market Elektronik Hizmetler ve Ticaret A.&Scedil; (&ldquo;Hepsiburada&rdquo;) taraf&inodot;ndan 6698 say&inodot;l&inodot; Ki&scedil;isel Verilerin Korunmas&inodot; Kanunu (&ldquo;KVKK&rdquo;) ve ilgili mevzuat kapsam&inodot;nda i&scedil; ba&scedil;vuru s&uuml;re&ccedil;lerinin y&uuml;r&uuml;t&uuml;lmesi amac&inodot;yla otomatik yollarla i&scedil;lenecektir. Detayl&inodot; bilgi i&ccedil;in l&uuml;tfen
   <em>
    Ayd&inodot;nlatma
   </em>
  </strong>
 </p>
 <p>
  <strong>
   <em>
    Metni&rsquo;ndeki
   </em>
   &Ccedil;al&inodot;&scedil;an Aday&inodot; (https://www.hepsiburada.com/kisisel-verilerin-korunmasi) ki&scedil;i kategorisini inceleyiniz.&rdquo;
  </strong>
 </p>
</div>


Assistant Compliance Officer

TCI Aircraft Interiors

<div>
 <p>
  TCI Aircraft Interiors, initially established in 2010, entered a new era in 2023 with the merger of Turkish Airlines subsidiaries TCI Cabin Interior, TSI Seat, and Cornea. Combining over a decade of experience with an innovative vision, TCI leverages its enhanced capabilities to provide cutting-edge solutions for both wide and narrow body aircrafts. As the only company in its field operating in T&uuml;rkiye, we proudly represent our country while setting new standards in the international aviation industry and continue our mission to provide the best values in the sector.
 </p>
 <p>
  <br/>
 </p>
 <p>
  We offer in our product range; economy and business class seats, galleys, lavatories, and in-flight entertainment and satellite internet (IFEC) systems for commercial aircrafts. TCI also provides the most innovative solutions to the aviation industry with products such as service trolleys, cargo containers, and seat power systems, which are widely used in aviation operations. The company operates with design, engineering, manufacturing, and R&amp;D capabilities at its facilities in Istanbul and Seattle, serving multiple aircraft types and catering to industry leaders such as Boeing, Airbus, and some of the world&rsquo;s leading airlines.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Bachelor's Degree in related Engineering Departments
  </li>
  <li>
   At least 3 years of experience in management systems and relevant aviation regulations and standards (e.g., FAA, EASA, DGCA, and IATA regulations)
  </li>
  <li>
   Strong knowledge and experience in EASA/SHGM Part 21 and Part 145 regulations, Safety Management Systems (SMS), Aerospace Standards (AS 9100, AS 9110), ISO 9001, ISO 17025, and ISO 14001
  </li>
  <li>
   Excellent proficiency in spoken and written English is required
  </li>
  <li>
   Proficiency in computer usage, including MS Office applications
  </li>
  <li>
   Confidential, open-minded, with strong analytical and synthesis skills
  </li>
  <li>
   Strong discussion skills with the ability to lead and develop people, along with excellent interpersonal and communication skills
  </li>
  <li>
   Ability to make effective technical and business decisions and identify areas for improvement
  </li>
  <li>
   High learning capability and adaptability to change
  </li>
  <li>
   Target-oriented with the ability to set priorities for effective time management
  </li>
  <li>
   Strong organizational and teamwork abilities
  </li>
  <li>
   High sense of responsibility and resilience under stress
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Description
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <ul>
  <li>
   Examining EASA/SHGM Part 21 and Part 145 regulations, Safety Management Systems (SMS), Aerospace Standards (AS) 9100, AS 9110, ISO 9001, ISO 17025, and ISO 14001 Environmental Management Systems (EMS) in detail, including concepts, purposes, content, and requirements; interpreting these and collaborating with the Manager to establish a Quality Management profile for the company.
  </li>
  <li>
   Designing, establishing, implementing, and maintaining processes and workflows for an integrated process management system.
  </li>
  <li>
   Supporting the Manager in the establishment of Quality, Safety, and Environmental Management Systems (QMS, SMS, and EMS).
  </li>
  <li>
   Managing QMS, EMS, and SMS documentation, including archiving activities, record-keeping, maintenance operations, and communication with all relevant authorities.
  </li>
  <li>
   Reporting to top management on activities, effectiveness, objectives, and issues related to improving the QMS, SMS, and EMS.
  </li>
  <li>
   Following up on external and internal corrective actions, monitoring and revising them as needed.
  </li>
  <li>
   Coordinating management review meetings and maintaining records of meeting minutes.
  </li>
  <li>
   Managing risks and opportunities within processes, participating in risk analysis studies, and coordinating with related departments.
  </li>
  <li>
   Reporting on the performance of the QMS, SMS, and EMS to top management.
  </li>
  <li>
   Managing relationships with representatives from all operational departments and regulatory authorities (FAA, DGCA, ICAO, EASA, etc.) concerning the development and management of TCI's QMS, SMS, and EMS.
  </li>
  <li>
   Implementing quality development and improvement tools such as APQP, FMEA, 8D, and 5Why analysis in TCI management systems.
  </li>
 </ul>
 <p>
 </p>
</div>


Quality Assurance Specialist

Envista Holdings

<div><p>Operating Company: DEXIS<br>
Location: Istanbul,Istanbul,TR<br>
Date Posted: November 11, 2025<br>
Req Number: R5024578</p></div><div></div>
<br><div><p><b>Job Description:</b></p> <p>Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.</p><p> </p><p><b>Job Requirements:</b></p> <p><b>Reports to Role</b>: Head of RA Regions &amp; Registrations</p><p></p> <p><b>Location</b> (HQ or Region, Country, Site):</p> <p>Istanbul, Turkey, EH TURKEY SA&#286;LIK &Uuml;R&Uuml;NLER&#304; VE H&#304;ZMETLER&#304; L&#304;M&#304;TED &#350;&#304;RKET&#304;. Fully remote</p><p></p> <p><b><i>PURPOSE </i></b><i>&ndash; in a few sentences, briefly describe the overall purpose of the role, i.e. why the role exists</i></p> <p>The Regulatory Affairs Specialist supports regulatory affairs activities for international product registration by providing regulatory documentation and stakeholder support to ensure the timely regulatory approvals and maintenance of products in compliance with local regulatory requirements.</p><p></p> <p>The Regulatory Affairs Specialist is accountable for timely execution of regulatory strategies to support launch activities and maintain compliance status for international product registration.</p> <p><b><i>ACCOUNTABILITIES </i></b><i>&ndash; describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following:</i></p> <p>The Regulatory Affairs Specialist is accountable for compliance and delivery for all assigned countries and registrations in Regions.</p> <p><b>Regions &amp; Registrations</b></p><ul> <li>Contribute to development and execution of regulatory strategies for respective department projects, compliance projects as well as lifecycle management activities.</li> <li>Contribute to execution of International RA support projects for market access to REGIONS and ensure all RA related elements &amp; requirements implemented.</li> <li>Align with local distributors and with local RA, understand requirements, and assists with the deliverables/ files related to preparing ROW submissions; uploads deliverables/ files into repository. Consults with others on these efforts as required.</li> <li>Prepare, order, and maintain oversight of all Free Sales Certificates, Certificates of Foreign Government and Country of Origin certificates requested for international regulatory approvals</li> <li>Prepare core documentation &quot;regulatory submission packages&quot; for new product registrations in international markets</li> <li>Prepare country specific documents for international regulatory approvals including, but not limited to manufacturer statements, Letters of Authorization and Power of Attorney</li> <li>Review submission documents prepared by local RA to be used in country registrations</li> <li>Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes</li> <li>Conduct regulatory release and delisting of products using specialized regulatory software</li> <li>Is aware of procedures and only makes decisions in line with procedure on simple topics</li> <li>Plan out workload to deliver on time, able to make adjustments when required and prioritizing work together with manager</li> <li>Prepare, and follow-up on International regulatory assessments for product changes</li> <li>Closely monitoring together with local country representatives guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets to ensure new requirements are caught, impact assessed and escalated if required</li> <li>Close gaps created due to changed or new local country requirements by initatin projects and/or incorporating into global processes.</li></ul><ul> <li>Support the provision of regulatory guidance to project teams in assigned projects and markets, in terms of requirements and related submission to support optimal timelines and required compliance levels.</li></ul><ul> <li>Support the assembly of documents and the submission to authorities in countries of responsibility</li> <li>Supports the monitoring of the regulatory environment and maintenance of the information resources</li> <li>Support internal and external audits in the audit preparation and audit back office</li> <li>Contributes and participates in the review of change requests to ensure compliance and the potential for regulatory submissions</li> <li>May assist with reviews of promotional materials.</li> <li>Has a yearly training program in place specified by manager.</li> <li>Support the creation and maintenance of regulatory procedures and templates.</li> <li>Can revise or create Technical Files.</li> <li>Support the review of labels and IFUs</li> <li>Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes</li> <li>Tracks and maintains files on current status of licenses, registrations and product information as per agreed formats in the different systems in use by the organization</li> <li>Can collect the regulatory compliance status of main countries, contribute to regulatory status of other regions of devices affected by HHE/Deviation/CAPA/Recall.</li> <li>Provide internal trainings on requirements for area under their responsibility.</li> <li>Knows and understands the EBS philosophy and employs it in daily RA activities and standard work.</li> <li>Able to provide input in terms of activities required to be added to a DM or VPM.</li> <li>Trained on PSP procedures to solve standard problems; analyzes information and standard practices to make judgments.</li></ul> <p><b><i>KNOWLEDGE, SKILLS &amp; EXPERIENCE </i></b><i>&ndash; </i><i>Functional/technical competencies specific to the role and required to perform the role</i></p> <p><b>Critical Knowledge and Qualifications: </b><i>(what the role holder must know; including any required general or professional qualifications/education)</i></p><ul> <li>A minimum of a Bachelor&rsquo;s degree from accredited college or university is required.</li> <li>Basic knowledge of medical device quality management systems such as 21 CFR Part 820 and ISO 13485.</li> <li>Basic knowledge of international legislation in some countries.</li> <li>Knowledge of main general documents required as FSC &amp; legalization process</li></ul> <p><b>Critical Skills/technical know-how: </b><i>(what the role holder must be able to do)</i></p><ul> <li>Fluency in English a must. Further languages is an advantage.</li> <li>Able to communicate effectively with team members, project team members, manager and other stakeholders; this includes: able to listen and grasp key information, able to clearly convey straightforward information, able to read non-verbal communication, such as reading body language and able to give short presentations to RA team on straightforward information</li> <li>Demonstrates and advocates for working together in the spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust.</li> <li>Seeks out diverse ideas, opinions and insights, and applies them in workplace.</li> <li>Works closely with direct team and project teams and starts building up network of colleagues, stakeholders, SMEs and customers.</li> <li>Is aware of procedures and regulations and is able to assess situation on simple topics</li> <li>Creates clarity and direction amid complexity and develops solutions</li> <li>Never compromises on patient safety.</li> <li>Have a positive attitude and 'can do' spirit</li> <li>Ability to be flexible and adaptable. Maintain a professional demeanor under pressure.</li> <li>Demonstrate a commitment to getting the job done right and on time and prioritizing work together with manager.</li> <li>Be able to manage several projects, tasks products and/or countries work load and takes ownership.</li> <li>Have attention to detail to task in hand but also start seeing bigger picture / wider process.</li> <li>Know when to ask questions.</li></ul><p></p> <p><b>Critical Experience:</b></p><ul> <li>Minimum 2 years' experience in regulatory affairs or associated field within medical device industry.</li></ul> <h2 class="jobSectionHeader"><b>COMPETENCIES &ndash; Essential for the role</b></h2> <p><i>Determine max. 6 competencies, refer to List and Definition of Competencies</i></p><ul> <li>Continuous Improvement</li> <li>Planning and Organizing</li> <li>Strategy execution</li> <li>Driving Execution</li> <li>Learning Orientation</li> <li>Actively contribute to successful team</li></ul><p> </p><p><b>Operating Company:</b></p> <p>DEXIS</p> <p>Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.</p></div>

Regulatory Affairs Specialist

Kraft Heinz

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 <strong>
  Job Description
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  <br/>
 </strong>
 <strong>
  About the Posiion
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  <br/>
 </strong>
 Regulatory Affairs Executive ensuring Food Regulatory Compliance and enabling market access for products. Managing product registrations with authority, as well as reviewing, verifying product information and coordinating documentation for regulatory submissions. Supporting regulatory strategies, maintaining strong relationships with local authorities and internal stakeholders to support business growth. Monitoring and analyzing legislative/regulation changes and their impact on our products- brands- and organization. Presenting the organization in various trade associations and industry groups to proactively manage food regulatory advocacy as well as keeping internal stakeholders informed through continuous monitoring of emerging regulations. You&rsquo;ll be directly reporting into Supplier &amp; External Manufacturing Sr Manager - East &amp; dotted-line reporting to Head of Legal T&uuml;rkiye.
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  Key Responsibilities
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 </strong>
 <ul>
  <li>
   Check the compliance of the products&rsquo; labels in Turkey against the relevant legislations- government guidelines and company policies. All brands the company produces and imports.
  </li>
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   Check the compliance of the health and nutritional and other claims against the relevant legislation.
  </li>
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   Support the Marketing team in providing and approving legislation of the products&rsquo; information relating to product functional - health - nutritional claims including ads and online marketing.
  </li>
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   Provide information and advice on legislation for product formulation- packaging- and labelling issues.
  </li>
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   Prepare product registration files with claim substantiation docs and follow up till registration is done.
  </li>
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   Be in direct contact with distributors or get support from 3rd party companies (for export destinations) to support and understand any new regulatory updates/ requirements.
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   Support the business with regulatory information relating to products produced and sold in other regions.
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   Work with cross country teams to ensure regulatory compliance of export and import products including filling necessary applications.
  </li>
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   Horizon scanning possible regulatory related changes within your region. Build and maintain relationships with the relevant authorities to maintain awareness of new food legislation and government guidance.
  </li>
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   Track- monitor and report completion of necessary changes that need to be done due to new regulations in order to prevent any penalties from authority.
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   Ensure that ingredients- formulas- labeling- and packaging are in full compliance with the local laws and regulations where the products are sold; and provide training to the organization on relevant regulatory topics
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   Monitor and provide advice/analysis on best practices from the market for the categories we play in &amp; share it consistently with other RA teams across the company
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  <li>
   Build presence in the local trade associations and industry groups as a forum to discuss upcoming or existing regulatory changes; and proactively monitor regulatory activities in our markets to address and influence proposed regulations to preserve the organization&rsquo;s freedom to operate
  </li>
  <li>
   Provide proposals for the amendment of existing or new regulations to support the interests of the organization
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  </li>
 </ul>
 <strong>
  Qualifications &amp; Experience
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 </strong>
 <ul>
  <li>
   Bacherlor&rsquo;s degree in Food Technology/ Pharmacy or related disciplines. Master degree is an advantage
  </li>
  <li>
   Minimum 3 years&rsquo; working experience in the field of regulatory affairs, preferably within an international environment.
  </li>
  <li>
   Familiar with Turkey food registration procedures and regulatory aspects.
  </li>
  <li>
   Good understanding of the commercial drivers of F&amp;B industry and an associated ability to provide advice/guidance that takes these into consideration
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   Analytical skills and attention to detail with the capability to appropriately define issues, questions, and data
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  <li>
   Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills
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   Ability to work both independently and as part of a team as required
  </li>
  <li>
   Be able to balance company commercial needs with compliance requirements
  </li>
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   Ability to think strategically and innovatively for resolution of regulatory issues
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  <li>
   Commitment to continued improvement in department processes and performance
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  <li>
   Strong team player, assisting others with workload peaks and the management of challenging situations
  </li>
  <li>
   Fluency in English and Turkish
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   <br/>
   <br/>
  </li>
 </ul>
 This position can be based in either Susurlul factory or &Idot;stanbul Headquarter.
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 <br/>
 <strong>
  About Us
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  <br/>
 </strong>
 The Kraft Heinz Company is one of the largest food and beverage companies in the world, with eight $1 billion+ brands and global sales of approximately $25 billion. We&rsquo;re a globally trusted producer of high-quality, great-tasting, and nutritious foods for over 150 years. Our brands are truly global, with products produced and marketed in over 40 countries. These beloved products include condiments and sauces, cheese and dairy, meals, meats, refreshment beverages, coffee, infant and nutrition products, and numerous other grocery products in a portfolio of more than 200 legacy and emerging brands.
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 No matter the brand, we&rsquo;re united under one vision To sustainably grow by delighting more consumers globally. Bringing this vision to life is our team of 39,000+ food lovers, creative thinkers, and high performers worldwide. Together, we help provide meals to those in need through our global partnership with Rise Against Hunger. We also stand committed to responsible, sustainable practices that extend to every facet of our business, our consumers, and our communities. Every day, we&rsquo;re transforming the food industry with bold thinking and unprecedented results. If you share our passion &ndash; and are ready to create the future, build a legacy, and lead as a global citizen &ndash; there&rsquo;s only one thing to do join our table and let&rsquo;s make life delicious!
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 <strong>
  Our Culture of Ownership, Meritocracy and Collaboration
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 We're not afraid to think differently. Embrace new ideas. Dream big. We empower our people at every level &ndash; from entry-level intern to senior leader &ndash; to own their work. We share a responsibility to think like Owners &ndash; to be mindful of the collective and sustained success of Kraft Heinz &ndash; which we apply to every situation, every day.
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 As part of Kraft Heinz, you're supported to grow and achieve. You&rsquo;re expected to bring your authentic self to work every day, to lead with humility, and drive outstanding performance at every level &ndash; and you&rsquo;ll be rewarded. You&rsquo;re given opportunities to leave a mark and build a legacy. But you won&rsquo;t do it alone. You&rsquo;re supported by passionate teammates along the way, and our collective, collaborative spirit fuels our incredible progress.
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 Employee Candidate Privacy Notice https //www.heinz.eu/turkey-candidate-privacy-policy
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 Location(s)
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 Istanbul Branch
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 <strong>
  Kraft Heinz is an Equal Opportunity Employer &ndash; Underrepresented Ethnic Minority Groups/Women/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity and other protected classes
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Regulatory Affairs Executive

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