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

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

Olympus Winter & Ibe GmbH (OWI) Chief Quality Officer from 01.02.2025, fulltime position, unlimited contract.

Join Olympus’ new and rapidly growing Digital Unit as the Regulatory Affairs Program Manager for Digital Strategy! In this role, you’ll shape and oversee regulatory strategies for cutting-edge digital products, collaborating closely with internal teams and external partners. You’ll be pivotal in ensuring compliance, driving best practices, and contributing to both the strategic and operational success of innovative digital solutions that transform current and future products.

Your Responsibilities

• Ensure that Digital Unit products and documentation meet regulatory requirements for US, EU, Japan, and other key markets.
• Support sustaining (compliance) for launched products, in conjunction with Olympus Regulatory Affairs team.
• Provide guidance and oversight to DU development teams in various aspects of Regulatory Affairs.
• Build and conduct regular trainings to ensure DU employees maintain best practices in regulatory aspects of product development.
• Support responses to regulatory body inquiries and support audits by regulatory bodies.
• Maintain expert current knowledge of appropriate regulations, legislation, best practices, and guidelines related to Artificial Intelligence, Software as a medical device, and Machine Learning.
• Assess impact of changes to applicable laws and regulations and identify impact to the DU and in collaboration with other stakeholders, develop strategies to address.
• Represent company in associations.
• Support partnership initiatives to strengthen the Olympus Digital and Systems Integration product portfolio through well-selected third-party offerings.

Your Qualification

• Bachelor’s degree required, Master’s preferred, with 5–7 years of regulatory affairs experience in the medical device industry, especially in SaMD.
• Extensive experience with regulatory requirements for Software as a Medical Device (SaMD), including Class I/II/III devices and AI/ML-enabled products.
• Strong knowledge of standards, guidance documents, and best practices for SaMD development, particularly around software, artificial intelligence, and machine learning.
• Proven experience collaborating with development teams using agile methodologies to manage regulatory requirements during product sprints.
• Demonstrated experience working with international regulatory bodies like the US FDA and European Notified Bodies on SaMD submissions and approvals.
• Ability to influence cross-functional teams on SaMD regulatory strategy, even without direct managerial authority.
• Excellent communication, problem-solving, and project management skills, particularly in a global and fast-paced environment.
• Expertise in maintaining compliance while fostering innovation and agility within SaMD product development.

Your Benefits

• 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 in-house company gym

About Olympus

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.

For more information, visit www.olympus-europa.com and follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA.

Further Information

Valuing diverse perspectives and lifestyles is one of our core values. We would therefore like to encourage all people to apply – regardless of gender, restrictions, nationality, ethnic and social origin, religion, world view, age as well as sexual orientation and identity.