Regulatory Affairs Program Manager (m​/f​/d) Digital Health

Regulatory Affairs Program Manager (m/f/d) Digital Health

Olympus Winter & Ibe GmbH (OWI)
Chief Quality Officer

The Regulatory Affairs (RA) Program Manager Digital Healthis responsible for coordinating and managing regulatory activities across the Smart Connected Care (SCC) Unit  SCC Unit is a new, global, high-growth area at Olympus focused on how digital technologies can help transform current and future products.

This individual will play a key role in establishing and assessing regulatory strategies and requirements for digital products and solutions, ensuring compliance with global medical device regulations. As part of a high-growth, innovative team, the RA Program Manager Digital Health will oversee collaboration between internal Olympus Regulatory Affairs Teams and external vendors as needed and will work closely with the DU's development teams to drive digital transformation in the medical technology space.

This role involves researching, recommending, and implementing regulatory best practices, contributing to both the strategic and operational functions of the SCC Unit.

• Develop and execute comprehensive regulatory strategies for diverse digital health solutions, including Artificial Intelligence (AI), Software as a Medical Device (SaMD), and connected technologies.
• Author and manage regulatory submissions including 510(k), De Novo, CE Marking, and other international filings as needed.
• Ensure regulatory compliance of digital health solutions across US, EU, Japan, and other strategic global markets.
• Collaborate closely with development teams to integrate regulatory considerations into agile sprint planning and product roadmaps.
• Proactively monitor evolving global regulatory frameworks, translating complex regulatory changes into actionable strategic recommendations for development teams.
• Assess impact of changes to applicable regulations, standards, and guidelines and recommend strategic adaptations in close collaboration with the DU development teams.
• Develop and maintain robust regulatory documentation systems, SOPs, and compliance frameworks tailored to digital health innovation.
• Design and implement regulatory training programs to elevate regulatory awareness and compliance capabilities across the Digital Unit
• Represent Olympus in influential industry associations and regulatory forums, shaping emerging digital health policy.

• Master degree preferred, Bachelor degree or comparable required
• Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with focus on Software driven medical devices (Software as a Medical Device) ideally with Artificial Intelligence / Machine Learning-enabled medical devices (2-3 years)
• Experience authoring and managing global regulatory submissions including 510(k), De Novo submissions, CE marking, and other international approvals.
• Expert knowledge of regulatory frameworks for Software as a Medical Device (SaMD) and Class I/II/III medical devices.
• Comprehensive experience supporting significant parts of the end-to-end product lifecycle management activities, especially for digital health solutions.
• Strong background in software development standards (IEC 62304, IEC 82304-1), guidance documents, and best practices for health software.
• Proficiency with health data privacy regulations (HIPAA, GDPR) and cybersecurity requirements in digital health ecosystems.
• Experience collaborating with agile development teams and integrating regulatory requirements into sprint planning and execution.
• Proven ability to make decisive regulatory determinations while managing large, complex digital health projects.
• Exceptional problem-solving skills that balance compliance requirements with agile development needs.
• Strong project management skills with the ability to coordinate cross-functional teams and manage multiple regulatory projects/initiatives.
• Passion to challenge the status quo and find new strategic directions - embraces change.

• 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 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

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,…