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

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 offering. Your qualification
• Bachelors degree required, Masters preferred, with 57 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 inhouse company gym