Senior Regulatory Affairs Manager

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.

Deine Aufgaben

We are offering this position as a fixed-term contract until 29 February 2028.

- Coordinate and facilitate the development of integrated regulatory strategies across the GI portfolio
- Alignment and harmonization of regulatory approaches across product groups and Regulatory Affairs teams
- Assessment of global regulatory requirements and translation into strategic recommendations
- Cross-functional stakeholder alignment on regulatory topics and decision-making
- Identification of regulatory synergies and process efficiency opportunities
- Support the governance, maintenance, and continuous improvement of the global License & Registration QMS processes
- Contribution to global RA standards, requirements, and process excellence initiatives
- Facilitation of collaboration, transparency, and knowledge sharing across global RA teams
- Communication of regulatory strategies and key regulatory developments to stakeholders
- Mentoring and professional support of Regulatory Affairs Managers (no direct reports)

Deine Qualifikationen

- Bachelor’s degree in Engineering, Life Sciences, Medical Technology, or a related field; Master’s degree preferred
- Several years of Regulatory Affairs experience within the medical device industry (minimum 5 years)
- Expertise in global medical device regulatory frameworks, standards, and requirements
- Experience with international regulatory authorities and organizations, including FDA and Notified Bodies
- Experience leading complex regulatory projects and regulatory decision-making activities
- Knowledge of Quality Management Systems (QMS), including License & Registration processes
- Experience collaborating with product development teams in agile and fast-paced environments
- Strong interpersonal skills with the ability to manage effective cross-functional working relationships (R&D, Manufacturing, Supply Chain, Quality, etc.)
- Ability to translate regulatory requirements into business-focused recommendations and align diverse stakeholders
- Excellent written and verbal communication skills in English
- Intercultural competence with experience working in global environments, ideally across Europe, Japan, and the US
- Strong influencing, relationship-building, mentoring, and continuous improvement mindset

Deine Vorteile

-30 days of annual leave
- Up to 40% 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