Regulatory Affairs Manager in Hamburg bei Olympus Europa SE & Co KG

Your responsibilities

• Develop Regulatory Strategies: Lead the development and implementation of regulatory strategies for product registrations (primary focus Asia Pacific and China) Collaborate with cross-functional teams to ensure alignment with business objectives and regulatory requirements
• Manage Registrations: Oversee the planning, preparation, submission, and maintenance of product registrations (primary focus Asia Pacific and China), including but not limited to new registrations, renewals and change registrations
• Stay Abreast of Regulatory Requirements: Monitor and analyze regulatory developments, guidelines, and requirements. Provide guidance and recommendations to stakeholders on the implications of regulatory changes for product development and commercialization
• Liaise with Regulatory Authorities: Establish and maintain effective relationships with regulatory authorities, industry associations, and external partners. Represent the company in regulatory meetings, discussions, and negotiations as needed
• Ensure Compliance: Ensure compliance with regulatory requirements and standards applicable to product registrations (primary focus Asia Pacific and China)
• Provide Regulatory Guidance: Serve as a subject matter expert on regulatory affairs (focused on Asia Pacific region and China), providing guidance and support to internal teams and stakeholders on regulatory matters, best practices, and compliance requirements

Your qualification

• Bachelor's degree in a related field such as Biomedical Engineering, Regulatory Affairs, or a relevant scientific discipline
• At least 4 years of progressive experience in regulatory affairs within the medical device industry
• Demonstrated experience in regulatory submissions (China and Asia Pacific region preferred)
• Experience in leading regulatory strategies and providing regulatory guidance to cross-functional teams
• Experience in regulatory intelligence, tracking changes in regulations, guidelines, and industry standards
• Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements and apply them to product development and registration strategies
• Exceptional written and verbal communication skills in English (and German, preferable), with the ability to effectively communicate regulatory requirements and strategies internally and externally
• Strong negotiation and interpersonal skills, with the ability to build and maintain effective relationships with regulatory agencies, industry partners, and internal stakeholders
• Strategic thinking and ability to anticipate regulatory challenges and opportunities

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