Regulatory Affairs Manager - Poland & Eastern Europe, Abbott Diabetes Care

Descripción del puesto:

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 processes, and tender documentation.
* Provide regulatory guidance for marketing materials and promotional activities.
* Monitor, interpret, and communicate regulatory intelligence for assigned countries.
* Advise internal teams on MDR, IVDR, and local regulatory requirements; support implementation of new or updated regulations.
* Coordinate regulatory strategy for design or labeling changes, including documentation review and authority interactions.
* Participate in internal and external audits with regulatory impact.
* Ensure compliance with Abbott's Quality System, ISO 13485, MDR/IVDR, and local regulations.
* Build and maintain strong relationships with regulatory authorities and internal stakeholders.
* Contribute to projects improving quality system efficiency and product quality.

Required Qualifications
* Min. Bachelor's degree in a scientific discipline.
* Solid understanding of MDR (EU 2017/745) requirements, including the CE-marking process, applicable regulatory frameworks to Medical Devices and ideally In Vitro Diagnostics (IVDs).
* Experience with in-country regulatory activities in Poland and at least one additional country in Eastern European markets / Russia
* Proven ability to lead regulatory strategy for product launches, design changes, and labeling updates.
* Strong organizational skills and ability to work effectively in a matrixed, geographically diverse environment.
* Excellent communication skills in English and Polish (both required). (Knowledge of Russian will be an advantage)
* Experience interacting with regulatory authorities and supporting cross-functional teams (R&D, Quality, Market Access, Marketing, Sales).

Apply Now

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is N/A
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Regulatory Operations

DIVISION:
ADC Diabetes Care

LOCATION:
Poland > Park Postepu : Building B

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Not Applicable