Global Principal Regulatory Affairs Manager Operations Notified Body Strategy in Hamburg bei Olympus Europa SE & Co KG (OEKG)

Your responsibilities

• Act as contact for the RA organization for Notified Body related matters
• Benchmark internal processes against best practices, aligning with commercial design requirements
• Contribute to improvement and maintenance of SOPs, Trainings, and Technology
• Develop and maintain the Notified Body related process standards, policies, guidelines, and KPIs
• Monitor key performance indicators of Notified Bodies
• Ensure alignment across all organization in regards of Notified Bodies
• Map out a global Notified Body strategy
• Drive quality mindset to reinforce the corporate brand and become a trusted, collaborative and preferred business partner across Olympus

Your qualification

• Bachelor’s degree in Engineering, Medical or Science (or similar) is required, Master’s degree preferred
• Experience in Regulatory Affairs / Quality within the medical device industry (minimum 5 years) with specific management experience, ideally in a matrix organization
• Experience in Regulatory Affairs / Quality within the Notified Bodies (minimum 5 years) with specific management experience, ideally in a matrix organization
• Experience in assembling/preparing writing, Medical Device Regulatory submissions for Health authority review and approval (e.g. CE Mark, 510(k), etc.
• Experience managing and operating QMS processes and systems
• Regulatory project management experience
• Proven track record of successful supported the implementation of regulatory documentation systems in a medical device company
• Travel will be required 10-20% of the time

Your competencies