Abbott Diabetes Care
Healthcare
RegulatoryAffairsManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Regulatory Affairs Manager at Abbott Diabetes Care. Skills: Regulatory affairs, MDR/IVDR, CE-marking. Lead regulatory activities for new product launches. Manage regulatory activities for product rollouts”
Industry & Context.
10% travel
What They're Looking For.
Must Have
Bachelor's degree in scientific discipline, Solid understanding of MDR requirements, Experience with CE-marking process, Experience with in-country regulatory activities in Poland, Experience with in-country regulatory activities in Eastern Europe/Russia, Proven ability to lead regulatory strategy, Excellent communication skills in English, Excellent communication skills in Polish
Nice to Have
Knowledge of IVD regulatory frameworks, Knowledge of Russian language
What You'll Do.
Lead regulatory activities for new product launches
Manage regulatory activities for product rollouts
Prepare technical documentation
Review technical documentation
Maintain technical documentation
Support in-country regulatory submissions
Support in-country notifications
Support in-country registrations
Support reimbursement processes
Support tender documentation
Provide regulatory guidance for marketing materials
Provide regulatory guidance for promotional activities
Monitor regulatory intelligence
Interpret regulatory intelligence
Communicate regulatory intelligence
Advise internal teams on MDR implementation
Advise internal teams on IVDR implementation
Advise internal teams on local regulatory support
Coordinate regulatory strategy for design changes
Coordinate regulatory strategy for labeling changes
Review documentation for changes
Interact with authorities on changes
Participate in internal audits
Participate in external audits
Ensure compliance with Quality System
Ensure compliance with ISO 13485
Ensure compliance with MDR
Ensure compliance with IVDR
Ensure compliance with local regulations
Build relationships with regulatory authorities
Maintain relationships with regulatory authorities
Build relationships with internal stakeholders
Maintain relationships with internal stakeholders
Contribute to projects improving quality system efficiency
Contribute to projects improving product quality
How You'll Work.
Team & Collaboration
Cross-functional teams; Global Regulatory; R&D; Quality; Market Access; Marketing; Sales; Government Affairs; Legal
Communication Scope
English; Polish
Full Job Description
## **JOB DESCRIPTION:** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **Working at Abbott** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: * Career development with an international company where you can grow the career you dream of . * A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. * A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. **About the Role** This position works out of our **Poland, Warsaw location** in the Abbott Diabetes Care (ADC) Division. We are seeking a highly skilled **Regulatory Affairs Manager** to join Abbott Diabetes Care and lead regulatory activities across the **EMEAP region** , with a focus on Poland and Eastern European markets. In this role, you will drive regulatory strategy, ensure compliance with global and local requirements, and support the timely introduction and lifecycle management of innovative diabetes care products. You will collaborate closely with cross‑functional teams including Global Regulatory, R&D, Quality, Market Access, Marketing, Sales, Government Affairs, and Legal. This position is ideal for a proactive, detail‑oriented regulatory professional who thrives in a matrixed, international environment. **What You’ll Do** * Lead and manage regulatory activities for new product launches and rollouts across EMEAP * Prepare, review, and maintain high‑quality technical documentation, including CE‑marking files for medical devices and IVDs. * Support in‑country regulatory submissions, notifications, registrations, reimbursement processe
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