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

Olympus Surgical Technologies Europe • Other • Hamburg, Berlin • 1d 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.

Join Olympus' new and rapidly growing Digital Unit as the Regulatory Affairs Program Manager for the 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.

Ensure that Digital Unit (DU) products and documentation meet regulatory requirements for US, EU, Japan and other key markets
Support sustainability (compliance) for launched products in conjunction with the 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 (SaMD) and machine learning
Assess impact of changes on applicable laws and regulations, identify impact on the DU and in collaboration with other stakeholders, develop strategies to address these impacts
Represent the company in associations
Support partnership initiatives to strengthen the Olympus Digital and Systems Integration product portfolio through well-selected third-party offering

Bachelor's degree required (Master's degree preferred) and long-standing regulatory affairs experience in the medical device industry, especially in Software as a Medical Device (SaMD)
Extensive experience with regulatory requirements for 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
Expertise in maintaining compliance while fostering innovation and agility within SaMD product development
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

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

GIMED1_DE

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