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regulatory affairs specialist

Perrigo Company plc

<div>
 At Perrigo, we are driven by our mission to
 <em>
  <strong>
   Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All
  </strong>
 </em>
 . 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
 <strong>
  <em>
   The Best Self-Care for Everyone
  </em>
 </strong>
 , we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more.
 <strong>
  We Are Perrigo
 </strong>
 . 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.
 <br/>
 <br/>
 Join us on our One Perrigo journey as we evolve to win in self-care.
 <br/>
 <br/>
 <strong>
  Description Overview
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 <strong>
  Scope of the Role
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Experience Required
  <br/>
  <br/>
 </strong>
 <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;
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Benefits
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 Find out more about
 <strong>
  Total Rewards
 </strong>
 at Perrigo.
 <br/>
 <br/>
 <strong>
  Hybrid Working Approach
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more
 <strong>
  here
  <br/>
  <br/>
 </strong>
 <strong>
  Applicants please note:
 </strong>
 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.
 <br/>
 <br/>
 <em>
  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
 </em>
</div>


Regulatory Affairs, Associate Specialist

Perrigo

<p></p><div><p>At Perrigo, we are driven by our mission to <b><i>Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All</i></b>. 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 <b><i>The Best Self-Care for Everyone</i></b>, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. <b>We Are Perrigo</b>. 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.</p><p></p><p><br>
Join us on our One Perrigo journey as we evolve to win in self-care.</p><p></p><div><div><div><h2 class="jobSectionHeader"><b><br>
Description Overview</b></h2></div><div><p>
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.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Scope of the Role</b></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"><b>
Experience Required</b></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><p><b>
Benefits</b><br>
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.</p><p>
Find out more about <b>Total Rewards</b> at Perrigo.</p><p></p><p><b><br>
Hybrid Working Approach</b><br>
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.</p><p></p><p><br>
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more <b>here</b></p><p></p><p><b><br>
Applicants please note:</b> 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.</p><p></p><p><i><br>
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</i></p></div>

Transmed

<div>
 Transmed Turkiye is a full-service distributor company across 13 countries, managing distribution, sales, and marketing for 35 leading brands. We strongly believe in putting people first &ndash; our customers, our teams, our partners.
 <br/>
 <br/>
 We are seeking a
 <strong>
  Regulatory Affairs Officer
 </strong>
 .
 <br/>
 <br/>
 <strong>
  Responsibilities
  <br/>
  <br/>
 </strong>
 <strong>
  JOB DESCRIPTION:
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Conducting preliminary evaluations of imported and planned-to-be-imported products for compliance with local and international regulations,
  </li>
  <li>
   Managing the regulatory approval processes for food, food supplements, cosmetics, cleaning products, and animal-origin products,
  </li>
  <li>
   Following up on official correspondence with the Ministry of Agriculture and Forestry, Ministry of Health, and Ministry of Environment, Urbanization and Climate Change,
  </li>
  <li>
   Registering and archiving products in the relevant ministry systems (e.g., GGBS, HBS),
  </li>
  <li>
   Continuously monitoring regulatory updates and inform relevant departments in a timely manner,
  </li>
  <li>
   Managing the follow-up and renewal processes of supplier quality certificates,
  </li>
  <li>
   Collaborating with Demand Planning, Category, and Business Development teams during new product launches,
  </li>
  <li>
   Working in cooperation with consultancy firms during permit and approval processes.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Qualifications
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   This position does not offer a hybrid / remote option.
  </li>
  <li>
   Bachelor&rsquo;s Degree in Food Engineering or in a related field,
  </li>
  <li>
   Minimum 2 years of experience in regulatory affairs for food, non-food, and cosmetic products,
  </li>
  <li>
   Preferably experienced in regulatory processes at consultancy or import companies,
  </li>
  <li>
   Advanced MS Office skills,
  </li>
  <li>
   Proficient in English,
  </li>
  <li>
   Proactive in following regulations, detail and result-oriented,
  </li>
  <li>
   Strong communication skills and a good team player,
  </li>
  <li>
   Completed military service for male candidates.
  </li>
 </ul>
</div>


Regulatory Affairs Officer

Ferring Pharmaceuticals, Inc.

<div><div>Job Description:</div><div>
Regulatory Affairs Associate</div><div></div><div>
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women&rsquo;s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.</div><div>
Joining our Regulatory team, you will be part of an empowering and collaborative culture where your work plays a key role in ensuring patient safety, regulatory compliance and sustainable access to medicines. By working closely with cross-functional teams and external stakeholders, you will support regulatory excellence, life-cycle management and the consistent maintenance of our portfolio. Your contribution helps ensure that high-quality therapies remain available, compliant and trusted throughout their entire life cycle.</div><div></div><div>
Ferring+You</div><div></div><div>
We are looking for a Regulatory Affairs Associate to join our team and take a key role in regulatory compliance, quality assurance, document governance, and cross-functional business support in line with local regulations and global procedures, reporting directly to the Regulatory Affairs Manager.</div><div></div><div>
Your day at Ferring</div><ul><li><div>
Act as Document Accountable Person (DAP) and Document Controller (DC), ensuring document lifecycle management, consistency, and compliance</div></li><li><div>
Serve as the main local regulatory contact and manage regulatory compliance activities</div></li><li><div>
Coordinate new drug approvals, including dossier preparation, submissions, and follow-up with local Health Authorities</div></li><li><div>
Manage regulatory submissions, variations, renewals, and product lifecycle activities</div></li><li><div>
Support and coordinate regulatory inspections and maintain validity of licenses and certificates</div></li><li><div>
Monitor regulatory intelligence, assess impact, and proactively communicate regulatory changes</div></li><li><div>
Ensure timely and accurate updates in global and local regulatory systems (e-CTD, Veeva Vault, Track Wise, etc.)</div></li><li><div>
Prepare, review, and approve artworks and labeling to support submissions and product launches</div></li><li><div>
Review promotional and non-promotional materials in line with local regulations and global procedures</div></li><li><div>
Support Quality Management System (QMS) implementation and sustainability, including local market release</div></li><li><div>
Support regulatory and pricing applications, including document coordination and pricing data monitoring</div></li></ul><div></div><div>
Behind our collaboration&hellip;There&rsquo;s you</div><ul><li><div>
University degree in Pharmacy</div></li><li><div>
Min. 2-3 years of practical experience in regulatory and quality assurance</div></li><li><div>
Know-how of interactions with regulatory authorities</div></li><li><div>
Experience with e-CTD, Veeva Vault, Track Wise, and pricing is a plus</div></li><li><div>
Eager to learn personality, team player approach, attention to details</div></li><li><div>
Fluent in English language (written and verbal)</div></li></ul><div></div><div>
People come first at Ferring</div><div></div><ul><li><div>
Get inspired from our commitment to advocate for everyone&rsquo;s right to build a family, no matter who you are, where you live or who you love</div></li><li><div>
Our inclusive support package &ndash; &ldquo;Building Families at Ferring&rdquo; provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role</div></li><li><div>
Parental leave for both birthing and non-birthing parents</div></li><li><div>
Extended support on family building journey</div></li></ul><div></div><div>
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member&rsquo;s contributions. Imagine the power of your career when it&rsquo;s Ferring + You.</div><div></div><div>
Behind our purpose&hellip; There&rsquo;s you</div><div>
If our mission and your vision are aligned, please apply.</div><div>
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.</div><div></div><div>
Location:</div>
Ferring Turkey</div>

Regulatory Affairs Associate

HUMAN KAPİTAL İNSAN KAYNAKLARI

<div><div>S&uuml;rekli / Tam Zamanlı</div>
<div></div><div><b>Referans Numarası :</b> 1981-2041-2025
</div><div>İşe Alınacak Kişi Sayısı : 1</div>
<div></div><div><p>T&uuml;rkiye - İstanbul (Asya)
</p></div>
<div></div><div><p><b>Pozisyon Seviyesi : </b>:Orta D&uuml;zey Y&ouml;netici</p>
</div><div></div><div><p><b>İş Alanı : </b>: Ruhsatlandırma</p>
</div><div><div><h4 class="jobSectionHeader"><b>Genel Nitelikler ve İş Tanımı :</b></h4>
</div><div><p>As <b>Human Kapital</b>, on behalf of our corporate client operating in the pharmaceutical industry, we are seeking an <b>International Regulatory Affairs Manager</b> with strong experience in overseas regulatory processes, solid knowledge of global regulations, and proven team management capabilities.</p><p></p><p><b>
Required Qualifications</b></p><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field,</li><li>
Minimum 10 years of experience in the pharmaceutical industry,</li><li>
Prior experience in team management with demonstrated leadership skills,</li><li>
Preferably experienced in preparing overseas regulatory submission dossiers in <b>CTD format</b>,</li><li>
Strong knowledge of global regulations and international health authorities,</li><li>
Familiar with technology transfer processes and <b>R&amp;D (Product Development)</b> activities,</li><li>
Advanced level of English,</li><li>
Proficient in MS Office applications,</li><li>
Strong communication skills and a collaborative team player,</li><li>
For male candidates, completion of military service,</li></ul><p>
Able to reside in <b>Istanbul Ataşehir&ndash;Kadık&ouml;y</b> area or nearby districts.</p><p>
For Apply; https://humancapital.com.tr/ilan/143/international-regulatory-affairs-manager</p><p></p><p><b>
Duties and Responsibilities</b></p><ul><li>
Monitoring and implementing international regulatory requirements of relevant countries&rsquo; health authorities,</li><li>
Preparing overseas regulatory submission dossiers in compliance with country-specific requirements and managing the submission process,</li><li>
Following up all post-submission processes until product approval and ensuring internal coordination,</li><li>
Establishing effective communication with relevant health authorities,</li><li>
Preparing packaging mock-ups for products to be marketed abroad in accordance with the local language, and managing and tracking design approval processes,</li><li>
Notifying relevant country authorities of variations and changes made to licensed products,</li><li>
Tracking license renewal processes,</li><li>
Working in close cooperation with the Factory Quality Control unit,</li><li>
Contributing to R&amp;D processes,</li><li>
Following up variation approval processes,</li><li>
Managing and supervising the assigned team.</li></ul><p></p><p><b>
HUMAN KAPİTAL Human Resources and Consulting Services Industry and Trade Limited Company</b> is a private employment agency operating with the authorization of the Turkish Employment Agency dated <b>20.06.2025</b> and numbered <b>228</b>.<br>
In accordance with Law No. <b>4904</b> of the Turkish Employment Agency, no benefit of any kind may be obtained from job seekers.<br>
Charging job seekers any fee is strictly prohibited.</p>
</div></div><div><div><h4 class="jobSectionHeader"><b>Aday Kriterleri</b></h4>
</div><div><ul><li><b>İlan Tarihi : </b>15.12.2025</li>
<li><b>Eğitim Seviyesi: </b>Lisans Mezun, Y&uuml;ksek Lisans Mezun</li>
<li><b>Yaşadığı Şehir:</b> İstanbul (Asya),
</li><li><b>Tecr&uuml;be Yılı:</b> 10-0 Yıl</li>
<li><b>Yabancı dil ve seviyesi:</b> İngilizce - ( Seviye : İleri)<br>
</li><li><b>Askerlik Durumu:</b> Yapıldı, Muaf
</li><li><b>Firmanın Tercih Ettiği Sekt&ouml;rler :</b> İla&ccedil; &Uuml;retim ve Satışı</li></ul></div></div></div>

INTERNATIONAL REGULATORY AFFAIRS MANAGER

ulrich medical

<div><div>Angestellt (Vollzeit) - m / w / d</div>
<div></div><div>15.12.2025
</div><div>Job-Nummer: req289</div>
<div><p>Bei <b>ulrich medical</b> begeistern wir uns f&uuml;r die Gesundheit und die Lebensqualit&auml;t von Menschen. Teilen Sie unsere Leidenschaft f&uuml;r <i>Medizintechnik</i> und widmen Ihre Energie gerne der Entwicklung und Vermarktung innovativer Produkte? Dann kommen Sie zu ulrich medical. Es erwartet Sie ein Unternehmen, in dem der Mensch im Mittelpunkt steht und Teamgeist gelebt wird, ein dynamisches Umfeld mit vielen M&ouml;glichkeiten sich beruflich und pers&ouml;nlich weiterzuentwickeln.</p>
</div><p></p><div><h2 class="jobSectionHeader"><b>Hier sind Sie gefragt</b></h2>
<ul><li>Sie erstellen eigenst&auml;ndig klinische Bewertungen (CEP/CER) inklusive der dazu notwendigen Recherchen (Literatur,
<br>
Beh&ouml;rdenmeldungen etc.) sowie SSCPs</li><li>
Sie fertigen selbst&auml;ndig PMS/PMCF-Pl&auml;ne und die dazu geh&ouml;rigen Berichte (PMCF-Bericht, PMS-Bericht, PSUR) an</li><li>
Sie arbeiten eng mit externen Dienstleistern zusammen (Statistikern, Klinischen Beratern, etc.)</li><li>
Sie betreuen die wissenschaftliche Begleitung unserer Produkte als Schnittstelle zwischen Kliniken, &Auml;rzten, Vertrieb,
<br>
Entwicklung, Produktmanagement, Risikomanagement und Marketing</li><li>
Sie vermitteln und verfolgen die Einhaltung der regulatorischen Anforderungen, inkl. deren &Auml;nderungen</li><li>
Sie aktualisieren dazugeh&ouml;rige Prozesse aufgrund regulatorischer &Auml;nderungen und optimieren diese im Sinne des Lean Managements</li><li>
Sie stellen klinische Daten und Bewertungen f&uuml;r internationale Zulassungen bereit</li><li>
Sie unterst&uuml;tzen bei der Planung und Betreuung klinischer Studien und werten diese mit aus</li></ul>
</div><p></p><div><h2 class="jobSectionHeader"><b>Das bringen Sie mit</b></h2>
<ul><li>Sie haben ein medizinisches, naturwissenschaftliches oder technisches Studium erfolgreich abgeschlossen oder verf&uuml;gen &uuml;ber eine vergleichbare Qualifikation mit entsprechenden Zusatzqualifikationen</li><li>
Sie bringen fundierte Kenntnisse bez&uuml;glich der gesetzlichen und regulatorischen Vorgaben im Bereich der Durchf&uuml;hrung, Interpretation und Publikation von wissenschaftlichen Studien im medizinischen Umfeld mit</li><li>
Zudem verf&uuml;gen Sie &uuml;ber 3-5 Jahre Berufserfahrung und kennen sich mit Medizinprodukten aus, aber auch ambitionierten Berufseinsteigern geben wir eine Chance</li><li>
Neben profunden Statistikkenntnissen &uuml;berzeugen Sie durch Ihre analytischen F&auml;higkeiten</li><li>
Sie bringen sehr gute Englischkenntnisse mit und sind im Umgang mit dem Office Paket sicher</li><li>
Sie runden Ihr Profil durch die F&auml;higkeit ab, Probleme wahrzunehmen, strukturiert L&ouml;sungen zu erarbeiten und komplexe Sachverhalte in interdisziplin&auml;ren Teams verst&auml;ndlich zu vermitteln</li></ul>
</div><p></p><div><h2 class="jobSectionHeader"><b>Das bieten wir Ihnen</b></h2>
<p>Freuen Sie sich &uuml;ber einen zukunftssicheren Arbeitsplatz an einem modernen Standort mit attraktiver Verg&uuml;tung. Als familienfreundliches <b>Unternehmen</b> legen wir Wert darauf, dass Sie Ihre beruflichen und privaten Ziele vereinbaren k&ouml;nnen und sich im Unternehmen wohlf&uuml;hlen. Dies unterst&uuml;tzen wir neben flexibler Arbeitszeitgestaltung durch vielf&auml;ltige Sozialleistungen, gesunde Verpflegung und Events abseits des Arbeitsalltags.</p>
</div><div><div><div><div><h2 class="jobSectionHeader"><b>Wir haben Ihr Interesse geweckt?</b></h2>
<div>Dann w&uuml;rden wir Sie gerne kennenlernen! Bewerben Sie sich einfach und komfortabel direkt &uuml;ber unser Online-Bewerbungsformular.</div></div></div></div></div></div>

Clinical Affairs Manager

Medtronic

<div><p>At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You&rsquo;ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
</p><p></p><h1 class="jobSectionHeader"><b>A Day in the Life
</b></h1><p></p><p>Medtronic is committed to advancing global healthcare by addressing the needs of more people, in more ways, and in more places around the world. United as one company, we accelerate meaningful innovation &mdash; and we can only succeed with the right people on our team.
</p><p></p><p>We are seeking a Regional Field Corrective Action (FCA) Coordinator to join Medtronic&rsquo;s Center-Led Post-Market Vigilance team. In this role, you will be responsible for the effective planning, coordination, and oversight of Field Corrective Actions within your assigned region, in alignment with Medtronic&rsquo;s established FCA procedures and work instructions. As the primary liaison between regional sales, marketing, and field teams; quality assurance; the Enterprise Core Quality Services (CQS) function; and global Operating Unit (OU) Quality leadership, you will ensure the timely and compliant execution of all FCA activities. This position plays a critical role in protecting patient safety and maintaining regulatory compliance by ensuring that all regional FCAs are carried out efficiently, accurately, and transparently.
</p><p></p><p><b>Responsibilities may include the following and other duties may be assigned:
</b></p><ul><li>Coordinating FCA Deployment: managing the regional rollout of FCAs, including communication with local/regional Quality and Regulatory Affairs (QARA) departments, field representatives, sales and marketing management.
</li><li>Documentation &amp; Compliance: ensuring all FCA-related documents, including the Global FCA Plan, Field Safety Notice, and Customer Acknowledgement forms, are documented according to Medtronic&rsquo;s work instructions, and that regulatory and quality requirements are met.
</li><li>Training &amp; Support: providing guidance and training to field staff on FCA procedures and best practices.
</li><li>Audit Support &amp; Notification: supporting OU and local Audit programs, including providing evidence of FCA Planning activities and appropriate competent authority or notified body notification when needed.
</li><li>Continuous Improvement: identifying opportunities to enhance FCA processes and collaborating with cross-functional teams to implement improvements.
</li></ul><p></p><p><b>Required Knowledge and Experience:
</b></p><ul><li>Bachelor&rsquo;s degree in Life Sciences or a related field.
</li><li>Fluency in English, both written and spoken.
</li><li>Minimum of 2 years of experience in quality systems or regulatory affairs, plus at least 2 years of project management experience in a regulated environment.
</li><li>Experience supporting quality system audits (preferred).
</li><li>Strong project management capabilities.
</li><li>Excellent written and verbal communication skills.
</li><li>Exceptional critical thinking and analytical skills.
</li><li>Ability and willingness to work onsite at least three days per week.
</li></ul><p></p><p><b>Physical Job Requirements
</b><br>
<br>
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
</p><p></p><h1 class="jobSectionHeader"><b>Benefits &amp; Compensation
</b></h1><p><b>Medtronic offers a competitive Salary and flexible Benefits Package
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A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.<br>
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</p>This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
<p></p><h1 class="jobSectionHeader"><b>About Medtronic
</b></h1><p>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
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Our Mission &mdash; to alleviate pain, restore health, and extend life &mdash; unites a global team of 95,000+ passionate people.
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We are engineers at heart&mdash; putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.</p></div><p></p>

Quality Systems Specialist

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