Regulatory Affairs Manager – EUDAMED (m/f/d)

Regulatory Affairs Manager – EUDAMED (m/f/d)

Olympus Winter & Ibe GmbH (OWI) is seeking a Regulatory Affairs Manager specializing in EUDAMED. Olympus Surgical Technologies Europe, a high-tech specialist within the Olympus Corporation, is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery, and reprocessing. With 2,600 employees across nine locations in EMEA and headquartered in Hamburg, the company excels in medical diagnostics and therapy, offering a broad range of modern endoscopic solutions.

Your Responsibilities

1. Act as the Subject Matter Expert (SME) for EUDAMED across the organization.
2. Lead all interactions with the EUDAMED database and ensure regulatory compliance.
3. Monitor evolving regulatory requirements and develop actionable strategies.
4. Serve as the primary liaison between internal stakeholders and external regulatory bodies.
5. Ensure accuracy and integrity of regulatory data in EUDAMED and related systems.
6. Conduct internal training sessions and maintain SOPs and work instructions.
7. Support the implementation of global systems like RIMS and Next Gen PLM from a regulatory perspective.
8. Act as the central contact point for EUDAMED-related topics globally and locally.

Your Qualifications

1. Minimum of 3 years of experience in Regulatory Affairs or Quality within the medical device industry.
2. Proven expertise managing global regulatory databases, especially EUDAMED.
3. Experience in global project management and regulatory submissions.
4. Collaborative mindset with the ability to work effectively in cross-functional teams.
5. Strong English communication skills; additional languages are a plus.

Your Benefits

• 30 days of annual leave.
• Up to 60% mobile work and flexible work hours.
• Holiday and Christmas bonuses.
• Corporate benefits discounts.
• Comprehensive pension scheme and capital-forming benefits.
• Company restaurant with live cooking and healthy options (subsidized).
• Employee Assistance Program supporting health and well-being.
• Subsidies for public transportation, free parking, and leasing options.
• Access to company sports groups and gym facilities.

About Olympus

Olympus is committed to making people\’s lives healthier, safer, and more fulfilling. As a global leader in medical technology, we collaborate with healthcare professionals to deliver innovative solutions that improve patient outcomes. With over 100 years of history, Olympus aims to contribute to society through products designed for optimal results.

For more information, visit and follow us on LinkedIn: linkedin.com/company/OlympusMedEMEA .

Our Inclusive Workplace

We value diversity and are dedicated to fostering an inclusive environment where everyone feels they belong. We encourage all talented individuals to apply and join our team.

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