Job Description
At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Within the Olympus Corporation, Olympus Surgical Technologies Europe (OSTE) is the global competence center for development, production and repair services for rigid endoscopy, bipolar high-frequency surgery and reprocessing. With a total workforce of about 3,600 employees at 14 locations in EMEA and its headquarters in Hamburg, the company stands for exceptional performance in medical technology and therapy and offers a full range of the most modern endoscopic applications from single products to procedure-oriented system solutions.
The Regulatory Affairs Manager ensures compliance of Digital Unit (DU) products with international regulations, provides regulatory guidance, supports product launch compliance and maintains expertise in evolving industry standards. Your key responsibilites:
- Ensure DU products comply with regulatory requirements for US, EU, Japan and key markets
- Provide regulatory oversight and guidance to development teams, focusing on AI, Software as a Medical Device (SaMD) and Machine Learning
- Support compliance for launched products with Olympus Regulatory Affairs
- Respond to regulatory body inquiries and manage communications with international agencies
- Maintain expert knowledge of relevant regulations and assess the impact of legislative changes
- Collaborate with stakeholders to develop strategies that address regulatory updates and ensure compliance
- Manage third-party vendors as required
- Collaborate with cross-functional teams to drive regulatory strategy and innovation
- University degree in relevant fields with several years of Regulatory Affairs experience in the medical device industry
- Expertise in SaMD, Class I/II/III medical devices, and AI/ML-enabled technologies
- Experience with international regulators (FDA, Notified Bodies) and agile development teams
- Strong ability to align digital, business and R&D leadership on regulatory needs
- Excellent problem-solving, communication and English language skills (written and verbal)
- Collaborative mindset, excited to work with cross-functional teams and embrace change
- Comfortable challenging the status quo and providing strategic direction
- 30 days of annual leave
- Up to 60% mobile work possible and 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