Ihre Aufgaben
- 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
Ihre Qualifikationen
- 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
Ihre Vorteile
-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