Senior Regulatory Affairs Manager (m/f/d)

Senior Regulatory Affairs Manager (m/f/d)

/ Fixed-term contract until 29 February 2028

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.

Your responsibilities

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)

Your qualifications

- 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

Your benefits

- 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

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.