Senior Regulatory Affairs Specialist Health Care

Vor 3 Tagen

Hamburg, Deutschland Beiersdorf AG Vollzeit

At Beiersdorf, we want to help people feel good about their skin - and our commitment goes far beyond caring for skin. For 140 years, we have developed innovative skin and body care products for well-known brands such as NIVEA, Eucerin, La Prairie, Hansaplast, and Labello. We act according to our purpose, WE CARE BEYOND SKIN, and take responsibility for our consumers, our employees, the environment and society.

Behind every brand, every product and every accomplishment are our more than 20,000 employees. It is for them that we live a culture of inclusion, respect and trust that is strongly aligned with our values CARE, COURAGE, SIMPLICITY and TRUST. We embrace diversity by valuing the uniqueness of each individual and being committed to equal opportunities for all.

**Your Tasks**:
Join our experienced team as a Senior Regulatory Affairs Specialist, where you will play a crucial role in ensuring our medical devices meet regulatory standards throughout their lifecycle. Your daily work will involve:

- **Regulatory Support**:Provide guidance during product development, ensuring compliance with EU MDR and other relevant regulations from concept to market launch.
- **Cross-Functional Collaboration**:Work closely with R&D, Marketing, Quality, Clinical, and Manufacturing teams to align on regulatory requirements and product safety.
- **Risk Management**:Create and maintain risk management files in accordance with ISO 14971, identifying and managing potential risks effectively.
- **Technical Documentation**:Prepare and review technical documentation (technical files, design dossiers) for regulatory submissions, ensuring accuracy and compliance for Class I to IIb devices.
- **Communication with Authorities**:Facilitate interactions with notified bodies and regulatory authorities, addressing any concerns to ensure timely approvals.
- **Global Compliance**:Collaborate with international regulatory counterparts to ensure compliance of our products in global markets.

**Your Profile**:

- ** Education**:University degree in a relevant life science or engineering field.
- **Experience**:At least first professional experience in regulatory affairs, specifically with medical devices.
- **Technical Skills**:Strong knowledge of EU Medical Device Regulation (MDR) and experience with technical documentation and risk management according to ISO 14971.
- **Communication**:Excellent communication skills, with the ability to work collaboratively in a team-oriented environment.
- **Organizational Skills**:Strong project management abilities and attention to detail, ensuring all tasks are completed efficiently.
- **Language Proficiency**:Fluent in English (technical and business), with additional languages being a plus.

Depending on qualifications and experience, the salary range is approximately 62,000 to 75,000 gross p.a.

**Additional information**:
If you have any questions, please contact our recruiter Regine Siebe on Tuesdays between 9 and 10 am via the telephone number: +49 40 4909 4956.

Have a look at our benefits: What we offer - Our Benefits | Beiersdorf

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