As a high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of 2,600 employees at nine locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical diagnostics and therapy, and offers a full range of the most modern endoscopic applications, from single products to procedure-oriented systems solutions.

Ihre Aufgaben

- Management of registration cases for product development projects and renewals
- Monitoring and interpretation of changes in official regulations with a country-specific focus
- Coordination of registration activities across multiple regions and support for distributors in preparing necessary documentation
- Support development of strategies for early access to market
- Develop and foster strong cross-functional collaboration with key stakeholders, including R&D and regional RA counterparts
- Contribution to standards boards and assessment of cost and business impact of registration cases
- Presentation of regulatory topics to third parties and mentoring of junior team members on regulatory matters

Ihre Qualifikationen

- Diploma or Master’s degree in Engineering or a related field (or equivalent experience)
- 5+ years of experience in a highly regulated industry in RA, with involvement in at least 10+ registration projects
- Strong knowledge of regulatory requirements in specific markets and project management expertise
- Advanced communication skills in English
- Cultural awareness and the ability to adapt to diverse international markets
- Exceptional self-management, organizational, and interpersonal skills
- Ability to explain complex regulatory concepts to non-regulatory stakeholders and junior team members

Ihre Vorteile

- 30 days of annual leave
- Up to 60% mobile work possible + flexible work time model with overtime compensation
- 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

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