Abbott Diabetes Care

Healthcare

RegulatoryAffairsManager

$215–310k ~AI est. Warsaw, Poland FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Manager candidates.

The Brief

“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.

Healthcare
Eligibility Requirements

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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