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

- Take over the coordination of sustaining activities within RA including change management, CAPA (Corrective and Preventive Actions) and Health Hazard Assessment (HHA) activities
- Representing RA in HHA related meetings and CAPA Boards
- Serve as RA SME for sustaining activities (operational work in product changes, CAPAs, HHAs)
- Function as the primary RA contact for interactions with local HHA, CAPA, and product change teams regarding operational and process-related matters
- Mentor and train RA colleagues on HHA, CAPA, and product change processes
- Drive continuous improvement of RA processes related to product lifecycle activities

Ihre Qualifikationen

- Bachelor, Diploma or Master’s degree in Engineering or related field (or equivalent experience)
- 5+ years of experience in regulatory affairs in medical device industry
- Sound knowledge of global regulatory frameworks and requirements
- Experiences supporting significant parts of lifecycle management activities including change management, CAPAs and/or Health Hazard Assessments
- Intrinsic knowledge of QMS processes/systems and experiences in process development
- Strong interpersonal skills with the ability to manage effective cross-functional working relationships and to explain complex regulatory concepts to non-regulatory stakeholders and junior team members
- Enhanced English writing and communication skills in an international environment, German skills beneficial

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 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

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