Regulatory Affairs Manager – EUDAMED (m/f/d) - #2163133

Your Responsibilities - Acting as the Subject Matter Expert (SME) for EUDAMED across our organization

• Leadership of all interactions with the EUDAMED database and ensuring regulatory compliance across our product portfolio
• Monitoring of evolving regulatory requirements and translation into actionable strategies for Olympus
• Serving as the primary liaison between internal stakeholders and external regulatory bodies
• Ensuring the accuracy and integrity of regulatory data in EUDAMED and related systems
• Conducting internal training sessions and maintaining relevant SOPs and work instructions
• Support of the implementation of global systems such as RIMS and Next Gen PLM from a regulatory perspective
• Acting as the central point of contact for EUDAMED-related topics—both locally and globally
  
  

Your qualification - A minimum of 3 years of experience in Regulatory Affairs or Quality within the medical device industry

• Proven expertise in managing global regulatory databases, with a strong focus on EUDAMED
• Solid experience in global project management and regulatory submissions
• A collaborative mindset and the ability to work effectively in cross-functional, matrixed environments
• Strong communication skills in English; additional languages are a plus
  
  

Your benefits - 30 days of annual leave

• Up to 60% mobile work possible + flexible work time model
• Holiday and Christmas bonuses
• Corporate benefits discounts for employees
• Comprehensive company pension scheme and capital-forming benefits
• Company restaurant with live cooking and healthy food (subsidized)
• Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
• Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
• Various subsidized company sports groups and access to the inhouse company gym
  
  

About Olympus At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

For more information, visit

www.olympus-europa.com

and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA .

Further information: Your future inclusive workplace awaits

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

We warmly encourage all who wish to bring their talents to Olympus to apply.