Regulatory Affairs Manager (m/f/d) Digital Products/ Software

Olympus Surgical Technologies Europe • Other • Hamburg, Berlin • 2d ago

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

GIMED1_DE

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