regulatory affairs specialist

Envista Holdings

<div>Operating Company: DEXIS 
Location: Istanbul,Istanbul,TR 
Date Posted: November 11, 2025 
Req Number: R5024578</div><div></div>
 <div>Job Description: 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. Job Requirements: Reports to Role: Head of RA Regions &amp; Registrations Location (HQ or Region, Country, Site): 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 PURPOSE &ndash; in a few sentences, briefly describe the overall purpose of the role, i.e. why the role exists 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. The Regulatory Affairs Specialist is accountable for timely execution of regulatory strategies to support launch activities and maintain compliance status for international product registration. ACCOUNTABILITIES &ndash; describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following: The Regulatory Affairs Specialist is accountable for compliance and delivery for all assigned countries and registrations in Regions. Regions &amp; Registrations<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> KNOWLEDGE, SKILLS &amp; EXPERIENCE &ndash; Functional/technical competencies specific to the role and required to perform the role Critical Knowledge and Qualifications: (what the role holder must know; including any required general or professional qualifications/education)<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> Critical Skills/technical know-how: (what the role holder must be able to do)<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> Critical Experience:<ul> <li>Minimum 2 years' experience in regulatory affairs or associated field within medical device industry.</li></ul> <h2 class="jobSectionHeader">COMPETENCIES &ndash; Essential for the role</h2> Determine max. 6 competencies, refer to List and Definition of Competencies<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> Operating Company: DEXIS 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.</div>

Regulatory Affairs Specialist

UTOPIA INDUSTRIES PVT LTD

Regulatory Compliance Officer/ Specialist &ndash; Dietary SupplementsEducation: Bachelor&rsquo;s/Master&rsquo;s degree in Pharmacy, Food Science, Nutrition, Biotechnology, or Regulatory Affairs.Experience: Minimum 3&ndash;5 years in product regulatory compliance, preferably in dietary supplements, cosmetics, or nutraceuticals.KeyResponsibilities:<ul><li>Ensure all dietary supplements comply with U.S. FDA Dietary Supplement regulations under the FD&amp;C Act and 21 CFR 111 (cGMP).</li><li>Review and verify supplier documentation, including Certificates of Analysis (COA), GMP certificates, NDI notifications, product dossiers, permitted ingredients, prohibited or restricted ingredients and formulation specifications.</li><li>Ensure scientific substantiation of ingredient functions and claims.</li><li>Review all product labels, claims and Amazon listings for compliance with FDA labeling guidelines (identity statement, net quantity, Supplement Facts, ingredient declaration, warnings).</li><li>Communicate with suppliers to ensure documentation completeness, GMP certification, facility registration, and FDA establishment listing and product conformity.</li><li>Evaluate supplier test data for microbial, heavy metals, and purity compliance.</li><li>Ensure all required premarket notifications (e.g., NDIN, if applicable) are filed or confirmed by the supplier, manage product listing on Amazon and FDA notification (via SPL) if needed.</li><li>Oversee post-market vigilance, including consumer complaint tracking, recall coordination, and adverse event reporting.</li><li>Work closely with QA/QC, Procurement, and Marketing teams to integrate regulatory compliance early in product selection.</li><li>Support packaging and labeling approval cycles before production.</li></ul>Job Type: Full-timeWork Location: In person

Acino

<div>Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. 
This position is based in Cairo, Egypt and will report directly to the Regulatory Affairs Manager, META. The role will be responsible to support on all the assigned Regulatory activities within the Non-Direct Markets (NDM) region (Sudan, Libya, Yemen, Morocco, Jordan and Lebanon). The role will also ensure all Regulatory activities are conducted in compliance with local regulations and company policies and SOPs. Manage Business Partners within the NDM region. 
Your Responsibilities will be: 
<ul>
<li>
Support the Regulatory Affairs Manager on all the assigned Regulatory activities within the NDM.</li>
<li>Keep up-to-date and archive all relevant regulations and Regulatory guidelines (Regulatory Intelligence); inform Global RA on any changes/updates to the local requirements.</li>
<li>Manage the preparation, submission, and follow-up of all regulatory applications in the assigned region (variations, product renewals, site registration renewals, new registrations etc.).</li>
<li>Initiate the preparation and translation of proofread printed artwork ensuring compliance with the registered Product Information.</li>
<li>Responsible of ordering and legalization of local CPP and other module 1 documents for local products.</li>
<li>Perform regulatory due diligence on module 1 for all assigned products for NDM according to internal process/guidance according to EU/local Region regulatory requirements.</li>
<li>Ensure that the regulatory file is complete and available for dispatch to the distributor and timely submitted to the local Health Authorities.</li>
<li>Work closely with Global RA on the submission strategy and the completion of the regulatory dossiers in line with local regulations.</li>
<li>Co-ordinate the responses to requests by the authorities during the evaluation process and check the correct handling of deficiency letters within a specific timeframe.</li>
<li>Create and maintain a full up-to-date database and archiving system for tracking the regulatory activities in the assigned region.</li>
<li>Adhere to Acino internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.</li>
<li>Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.</li>
<li>All trainings to be completed as per training plan.</li></ul> 


Your Profile: 
<ul>
<li>
Education in Pharmacy, natural Sciences or relevant discipline.</li>
<li>Minimum of 3 years&rsquo; experience working in the Pharmaceutical industry in Regulatory Affairs and extensive experience in preparation and submission of Regulatory files to local Competent Authorities in the region.</li>
<li>Proven ability to effectively work collaboratively in cross functional teams.</li>
<li>Ability to work in a highly dynamic business environment.</li>
<li>Cross-cultural awareness and ability to work across geographical markets.</li>
<li>Multi-task ability and work well under pressure and tight deadlines.</li></ul> 


This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</div>

Regulatory Affairs Specialist NDM

Bio-Techne

<div>By joining Bio-Techne, you&rsquo;ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Pay Range:
$62,300.00 - $102,350.00
POSITION SUMMARY
Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files.
Perform additional duties as assigned.
ESSENTIAL FUNCTIONS
<ul><li>Works in the regulatory affairs department on assigned projects.
</li><li>Maintain regulatory files.
</li><li>Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.
</li><li>Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.
</li><li>Review and approve documents, labels, and other documentation.
</li><li>Assist with design control activities.
</li><li>Assist in Risk Management activities.
</li><li>Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance with the job.
</li><li>Perform additional duties as assigned.
</li></ul>Education and Experience:
<ul><li>A Bachelor&rsquo;s degree with 2-4 years of relevant experience.
</li><li>Or, a Master&rsquo;s degree with up to 3 years of relevant experience
</li></ul>Knowledge, Skills, and Abilities:
<ul><li>Attention to detail and organizational skills are required
</li><li>Working knowledge of Microsoft Word and Excel are required
</li><li>Computer entry, typing, or electronic document filing skills are required.
</li><li>Must be able to work in a fast-faced environment where multitasking is required
</li><li>Must have excellent verbal and written communication skills
</li><li>Knowledge of technical, regulatory, quality and production management systems
</li><li>Knowledge of documentation principles and processes
</li><li>Skills in accuracy, clarity and proofreading
</li><li>Skills in problem solving, identifying root cause and appropriately evaluating a course of actions
</li><li>Knowledge of global regulations associated with in-vitro diagnostics
</li><li>Technical document writing skills
</li></ul><div><div><div><div>Why Join Bio-Techne:
<ul><li><h3 class="jobSectionHeader">We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
</h3></li><li><h3 class="jobSectionHeader">We invest in our employees&rsquo; financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
</h3></li><li><h3 class="jobSectionHeader">We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
</h3></li><li><h3 class="jobSectionHeader">We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
</h3></li><li><h3 class="jobSectionHeader">We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
</h3></li><li><h3 class="jobSectionHeader">We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
</h3></li></ul>Bio-Techne is an E-Verify Employer in the United States.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.</div></div></div></div></div>

Advanced Regulatory Affairs Specialist

HRCONSOL

HRCONSOL is Hiring | Regulatory Affairs Specialist (Cosmetics, Skincare &amp; Nutraceuticals)HRCONSOL is hiring for a leading E-Commerce company in Karachi and we are looking for a highly skilled Regulatory Affairs Specialist with strong expertise in Cosmetics, Skincare, and Nutraceuticals.Location: Karachi (On-site) Salary: PKR 100,000 &ndash; 300,000 + Benefits Apply at: jobs@hrconsol.comJob ResponsibilitiesCosmetics &amp; Skincare Regulatory Compliance<ul><li>Evaluate suppliers to ensure compliance with U.S. FDA MoCRA, ISO 22716 (Cosmetic GMP), and ingredient safety standards.</li><li>Review &amp; approve supplier documentation including COA, SDS, CPSR, GMP certificates, test reports, ingredient lists, MoCRA filings, and marketing claims.</li><li>Maintain complete compliance documentation for each product (formulation data, safety assessments, labeling proofs, MoCRA listings).</li><li>Validate Responsible Person (RP) arrangements and import compliance as per FDA rules.</li><li>Verify supplier labeling and artwork according to MoCRA &amp; FTC advertising guidelines.</li><li>Coordinate with suppliers for adverse event monitoring, recall readiness, risk communication protocols, and reporting duties under MoCRA.</li><li>Liaise with FDA, Regulatory Consultants, and RPs for submissions &amp; resolving compliance issues.</li><li>Track and interpret updates in MoCRA, FDA guidance, and global cosmetic regulations; advise management on potential impacts and compliance requirements.</li></ul>Nutraceuticals (Plus Point)<ul><li>Review compliance documentation as per dietary supplement regulations (FDA/USP standards).</li><li>Support import approvals, labeling validation, ingredient verification, and claim assessments.</li></ul>Who Should Apply?Candidates with strong experience in Cosmetic Regulatory Affairs, US FDA MoCRA, ISO 22716, labeling compliance, and supplier documentation review are highly encouraged to apply.Apply Now: jobs@hrconsol.com Be part of a top-tier e-commerce brand scaling globally!Job Type: Full-timePay: Rs100,000.00 - Rs300,000.00 per monthWork Location: In person

Regulatory Affairs Specialist (Cosmetics, Skincare & Nutraceuticals)

Amerikan Hastanesi

<div>
 
 Stembio (
 
 Ko&ccedil; Holding/Ko&ccedil; Healthcare
 
 i&scedil;tiraki),
 
 Mezenkimal K&ouml;k H&uuml;creler (MSC), Eksozomlar, &Idot;mm&uuml;noterapi &Uuml;r&uuml;nleri, Kordon Kan&inodot; Bankalama ve Doku Greftleri
 
 &uuml;retimi ve haz&inodot;rlanmas&inodot; konusunda uzmanla&scedil;m&inodot;&scedil;, ileri teknolojiye sahip bir
 
 cGMP laboratuvar&inodot;d&inodot;r
 
 . Kalite kontrol ve validasyon s&uuml;re&ccedil;lerine b&uuml;y&uuml;k &ouml;nem vererek,
 
 y&uuml;ksek kaliteli ve reg&uuml;lasyonlara uygun
 
 h&uuml;cresel tedavi &uuml;r&uuml;nleri sunmay&inodot; taahh&uuml;t ediyoruz.
 
 
 
 
 
 Yenilik&ccedil;i &uuml;r&uuml;n portf&ouml;y&uuml;m&uuml;zde &mdash; ATMP&rsquo;ler, t&inodot;bbi cihazlar ve kozmetik s&inodot;n&inodot;f biyolojik &uuml;r&uuml;nler dahil &mdash; reg&uuml;lasyon stratejilerini y&uuml;r&uuml;tecek ve destekleyecek, erken geli&scedil;tirme a&scedil;amas&inodot;ndan klinik &ccedil;al&inodot;&scedil;ma izinlerine ve &uuml;r&uuml;n ticarile&scedil;tirmeye kadar t&uuml;m s&uuml;re&ccedil;lerde T&Idot;TCK, ard&inodot;ndan EMA (Avrupa) ve FDA (ABD) &ccedil;er&ccedil;evelerine uygun reg&uuml;lasyon uyumlulu&gbreve;unu sa&gbreve;lamaktan sorumlu
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere bir
 
 Reg&uuml;lasyon Uzman&inodot;
 
 aray&inodot;&scedil;&inodot;nday&inodot;z.
 
 
 
 
 
 E&gbreve;er Ar-Ge, Kalite ve &Uuml;retim ekipleriyle yak&inodot;n i&scedil; birli&gbreve;i i&ccedil;inde &ccedil;al&inodot;&scedil;arak Stembio &uuml;r&uuml;nlerinin uluslararas&inodot; standartlara uygun ve hem yerel hem k&uuml;resel pazarlara haz&inodot;r hale getirilmesi konusunda yetkin oldu&gbreve;unuzu d&uuml;&scedil;&uuml;n&uuml;yorsan&inodot;z, ba&scedil;vurunuzu bekliyoruz!
 
 
 
 
 
 
 Genel Nitelikler
 
 
 
 
 
 <ul>
 <li>
 Biyolojik Bilimler, Biyoteknoloji, Eczac&inodot;l&inodot;k, Biyomedikal M&uuml;hendisli&gbreve;i, Kimya veya ilgili bir alanda lisans veya &uuml;zeri derece.
 </li>
 <li>
 Tercihen biyoteknoloji, ila&ccedil; veya t&inodot;bbi cihaz sekt&ouml;rlerinde en az 5 y&inodot;l Reg&uuml;lasyon alan&inodot;nda deneyim.
 </li>
 <li>
 ATMP, GMP, CE i&scedil;areti, MDR/IVDR ve klinik &ccedil;al&inodot;&scedil;ma d&uuml;zenlemeleri hakk&inodot;nda sa&gbreve;lam bilgi.
 </li>
 <li>
 K&uuml;resel reg&uuml;lasyon &ccedil;er&ccedil;evelerine h&acirc;kimiyet:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP ve cihaz kay&inodot;tlar&inodot;, klinik &ccedil;al&inodot;&scedil;ma izinleri
 
 
 
 Avrupa:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 K&uuml;resel:
 
 FDA (CBER), ICH k&inodot;lavuzlar&inodot;, ISO standartlar&inodot;
 
 
 
 
 <ul>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik belgeler ve klinik dok&uuml;mantasyon haz&inodot;rlama deneyimi.
 </li>
 <li>
 T&uuml;rk&ccedil;e ve &Idot;ngilizce yaz&inodot;l&inodot;/s&ouml;zl&uuml; ileti&scedil;im becerileri g&uuml;&ccedil;l&uuml;.
 </li>
 <li>
 &Ccedil;ok disiplinli ekiplerle &ccedil;al&inodot;&scedil;abilen, &ouml;ncelik y&ouml;netimi kuvvetli, dinamik ortamlarda etkin &ccedil;al&inodot;&scedil;abilen.
 </li>
 <li>
 Etik de&gbreve;erlere sahip, d&uuml;zenli, detaylara &ouml;nem veren ve reg&uuml;lasyon bilimi ile yenili&gbreve;e tutkulu.
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 
 
 Reg&uuml;lasyon Stratejisi ve &Uuml;r&uuml;n Geli&scedil;tirme
 
 
 
 
 
 <ul>
 <li>
 Stembio&rsquo;nun &uuml;r&uuml;n portf&ouml;y&uuml; i&ccedil;in reg&uuml;lasyon stratejilerini geli&scedil;tirmek ve uygulamak.
 </li>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma onaylar&inodot;, GMP sertifikasyonlar&inodot; ve ruhsat ba&scedil;vurular&inodot;n&inodot; (T&Idot;TCK, EMA, FDA) planlamak ve y&ouml;netmek.
 </li>
 <li>
 Ba&scedil;vuru ve onay takvimlerini belirleyerek, i&ccedil; ekiplerle koordinasyon i&ccedil;inde hedeflenen lansman tarihlerine ula&scedil;&inodot;lmas&inodot;n&inodot; sa&gbreve;lamak.
 </li>
 <li>
 K&uuml;resel &uuml;r&uuml;n dosyalar&inodot;n&inodot; yerel reg&uuml;lasyon formatlar&inodot;na uyarlamak ve gerekli ek dok&uuml;mantasyonu haz&inodot;rlamak.
 </li>
 <li>
 Yeni endikasyonlar, teknoloji transferleri ve i&scedil; birlikleri i&ccedil;in reg&uuml;lasyon due diligence &ccedil;al&inodot;&scedil;malar&inodot;na destek vermek.
 </li>
 </ul>
 
 
 
 
 
 Reg&uuml;lasyon Uyumu ve Kurumsal &Idot;leti&scedil;im
 
 
 
 
 
 <ul>
 <li>
 T&uuml;rkiye, Avrupa Birli&gbreve;i ve ABD&rsquo;deki ATMP, t&inodot;bbi cihaz ve kozmetik mevzuatlar&inodot;ndaki geli&scedil;meleri takip etmek ve yorumlamak.
 </li>
 <li>
 Reg&uuml;lasyon kurumlar&inodot;yla (T&Idot;TCK, EMA, FDA, Onaylanm&inodot;&scedil; Kurulu&scedil;lar) aktif ileti&scedil;im y&uuml;r&uuml;tmek, denetimlerde ve incelemelerde Stembio&rsquo;yu temsil etmek.
 </li>
 <li>
 GMP ve reg&uuml;lasyon denetimlerine y&ouml;nelik haz&inodot;r olma durumunu sa&gbreve;lamak, denetim cevaplar&inodot;n&inodot; ve CAPA s&uuml;re&ccedil;lerini y&ouml;netmek.
 </li>
 <li>
 T&uuml;rkiye ve AB&rsquo;de ATMP alan&inodot;ndaki reg&uuml;lasyon &ccedil;er&ccedil;evesini &scedil;ekillendiren sekt&ouml;r giri&scedil;imlerinde aktif rol almak.
 </li>
 </ul>
 
 
 
 
 
 Standartlar, Sertifikasyon ve Dok&uuml;mantasyon
 
 
 
 
 
 <ul>
 <li>
 Ge&ccedil;erli uluslararas&inodot; standartlara (ISO 13485, ISO 10993, EN, IEC, ICH Q serisi) ve y&ouml;netmeliklere (CE i&scedil;areti, MDSAP, MDR, IVDR) uygunlu&gbreve;u sa&gbreve;lamak.
 </li>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik dok&uuml;mantasyon, etiketleme ve kullan&inodot;m k&inodot;lavuzlar&inodot;n&inodot; haz&inodot;rlamak, g&ouml;zden ge&ccedil;irmek ve g&uuml;ncel tutmak.
 </li>
 <li>
 Sertifikasyon s&uuml;re&ccedil;lerini (&ouml;r. CE, TSE, Eurovent, PED) koordine etmek; akredite test laboratuvarlar&inodot; ve sertifikasyon kurulu&scedil;lar&inodot;yla ileti&scedil;imi y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 Klinik &Ccedil;al&inodot;&scedil;malar ve Pazar Sonras&inodot; Faaliyetler
 
 
 
 
 
 <ul>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma ba&scedil;vurular&inodot;, tadilatlar&inodot; ve yenilemelerini T&Idot;TCK ve EMA &ccedil;er&ccedil;evelerinde desteklemek.
 </li>
 <li>
 ATMP&rsquo;lere y&ouml;nelik k&uuml;resel klinik ara&scedil;t&inodot;rma ortam&inodot;n&inodot; takip etmek ve Klinik &Ccedil;al&inodot;&scedil;ma Yetkilendirmesi (CTA) dosyalar&inodot;n&inodot;n haz&inodot;rlanmas&inodot;na katk&inodot; sa&gbreve;lamak.
 </li>
 <li>
 Onayl&inodot; &uuml;r&uuml;nler i&ccedil;in pazar sonras&inodot; g&ouml;zetim, g&uuml;venlilik raporlamas&inodot; ve s&uuml;rekli emniyet g&uuml;ncellemelerini y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 &Idot;&ccedil; Kalite ve S&uuml;re&ccedil; Entegrasyonu
 
 
 
 
 
 <ul>
 <li>
 Reg&uuml;lasyon ve GMP standartlar&inodot;na uygunlu&gbreve;u sa&gbreve;lamak &uuml;zere i&ccedil; denetimler ger&ccedil;ekle&scedil;tirmek.
 </li>
 <li>
 Kalite G&uuml;vence, Ar-Ge, &Uuml;retim ve Hukuk ekipleriyle i&scedil; birli&gbreve;i i&ccedil;inde &uuml;r&uuml;n ya&scedil;am d&ouml;ng&uuml;s&uuml;n&uuml;n her a&scedil;amas&inodot;nda reg&uuml;lasyon entegrasyonunu sa&gbreve;lamak.
 </li>
 <li>
 Uyumsuzluk risklerini tespit etmek ve proaktif &ouml;nleme stratejileri geli&scedil;tirmek.
 </li>
 </ul>
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
 
 
 
 
 -------------------------------------------------------------------------------------------------------------
 
 
 
 
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of Mesenchymal Stem Cells (MSCs), Exosomes, Immunotherapy Products, Cord Blood Banking, and Tissue Grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking for a qualified and experienced
 
 Regulatory Affairs Specialist
 
 
 for Stembio,
 
 who
 
 
 will be responsible for ensuring regulatory compliance from early development to clinical trial authorization and product commercialization, initially under Turkish Medicines and Medical Devices Agency (T&Idot;TCK), and subsequently through EMA (Europe) and FDA (U.S.) frameworks,
 
 
 to lead and support regulatory strategies across Stembio&rsquo;s innovative product lines &mdash; including ATMPs, medical devices, and cosmetic-grade biologics.
 
 
 
 
 
 If you are passionate about creating close collaboration with R&amp;D, Quality, and Production teams to ensure Stembio&rsquo;s products meet international standards and are launch-ready for both local and global markets, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s or higher degree in Biological Sciences, Biotechnology, Pharmacy, Biomedical Engineering, Chemistry, or a related discipline.
 </li>
 <li>
 Minimum 5 years of experience in Regulatory Affairs, ideally within the biotechnology, pharmaceutical, or medical device sectors.
 </li>
 <li>
 Solid understanding of ATMP, GMP, CE marking, MDR/IVDR, and clinical trial regulations.
 </li>
 <li>
 Familiarity with global regulatory frameworks:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP and Device Registration, Clinical Trial Authorization)
 
 
 
 Europe:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 Global:
 
 FDA (CBER), ICH guidelines, ISO standards
 
 <ul>
 <li>
 Experience in preparing and maintaining product registration files, technical documentation, and clinical dossiers.
 </li>
 <li>
 Strong communication skills in Turkish and English (both written and spoken).
 </li>
 <li>
 Ability to work effectively in cross-functional teams and manage multiple priorities in a dynamic environment.
 </li>
 <li>
 Ethical, organized, and detail-oriented mindset with a passion for regulatory science and innovation.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 
 Regulatory Strategy &amp; Product Development
 
 
 
 
 
 <ul>
 <li>
 Develop and execute regulatory strategies for Stembio&rsquo;s Product Pipeline.
 </li>
 <li>
 Plan and manage regulatory submissions for clinical trial approvals, GMP certifications, and marketing authorizations under T&Idot;TCK, EMA, and FDA.
 </li>
 <li>
 Define submission and approval timelines, coordinating with internal teams to meet launch targets.
 </li>
 <li>
 Adapt global product dossiers to local regulatory formats and gather supplementary documentation as needed.
 </li>
 <li>
 Support regulatory due diligence for new indications, technology transfers, and collaborations.
 </li>
 </ul>
 
 
 
 
 
 Regulatory Compliance &amp; Institutional Liaison
 
 
 
 
 
 <ul>
 <li>
 Monitor and interpret evolving legislation on ATMPs, medical devices, and cosmetics across T&uuml;rkiye, EU, and the U.S.
 </li>
 <li>
 Maintain active communication with regulatory bodies (T&Idot;TCK, EMA, FDA, Notified Bodies) and represent Stembio during inspections and audits.
 </li>
 <li>
 Ensure inspection-readiness for GMP and regulatory audits; manage audit responses and CAPAs.
 </li>
 <li>
 Engage with industry associations to support advocacy initiatives shaping the Turkish and EU ATMP landscape.
 </li>
 </ul>
 
 
 
 
 
 Standards, Certification &amp; Documentation
 
 
 
 
 
 <ul>
 <li>
 Ensure compliance with applicable international standards (ISO 13485, ISO 10993, EN, IEC, ICH Q-series) and directives (CE marking, MDSAP, MDR, IVDR).
 </li>
 <li>
 Prepare, review, and maintain technical documentation, including product registration files, device master records, labeling, and instructions for use.
 </li>
 <li>
 Coordinate certification processes (e.g., CE, TSE, Eurovent, PED) and liaise with accredited test laboratories and certification bodies.
 </li>
 </ul>
 
 
 
 
 
 Clinical Trials &amp; Post-Market Activities
 
 
 
 
 
 <ul>
 <li>
 Support clinical trial submissions, amendments, and renewals under T&Idot;TCK and EMA frameworks.
 </li>
 <li>
 Track the global clinical trial landscape for ATMPs and contribute to dossier compilation for Clinical Trial Authorization (CTA).
 </li>
 <li>
 Oversee post-market surveillance, vigilance reporting, and continuous safety updates for approved products.
 </li>
 </ul>
 
 
 
 
 
 Internal Quality &amp; Process Integration
 
 
 
 
 
 <ul>
 <li>
 Conduct internal audits to ensure adherence to regulatory and GMP standards.
 </li>
 <li>
 Collaborate with Quality Assurance, R&amp;D, Production, and Legal teams to ensure full regulatory integration across the product lifecycle.
 </li>
 <li>
 Identify compliance risks and develop proactive mitigation strategies.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
</div>

Stembio - Regülasyon Uzmanı / Regulatory Affairs Specialist

Perrigo

<div>At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. 
Join us on our One Perrigo journey as we evolve to win in self-care.<div><div><div><h2 class="jobSectionHeader"> 
Description Overview</h2></div><div>
In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality &amp; Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.</div></div><div><div><h2 class="jobSectionHeader">
Scope of the Role</h2></div><div><ul><li>
Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;</li><li>
Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;</li><li>
Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;</li><li>
Maintain regulatory files and data systems in compliance with SOPs;</li><li>
Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;</li><li>
Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;</li><li>
Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;</li><li>
Support in the communication with local regulatory authorities regarding license applications and notice of change.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Experience Required</h2></div><div><ul><li>
University Degree in a Scientific Subject;</li><li>
Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;</li><li>
Excellent communicator in Turkish and English;</li><li>
Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;</li><li>
Eye for detail, punctual, well organized;</li><li>
Being flexible and adaptable to change;</li><li>
Ability to support several concurrent projects/products simultaneously;</li></ul></div></div></div>
Benefits 
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo. 
Hybrid Working Approach 
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. 
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more here 
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. 
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo</div>

Regulatory Affairs, Associate Specialist

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