Regulatory Affairs Director

vor 4 Wochen

Hamburg, Hamburg, Deutschland Olympus Vollzeit

Job Summary

Olympus is seeking an experienced Senior Regulatory Affairs Manager to lead and manage our EU-MDR and global regulatory operations. This pivotal role will act as the Subject Matter Expert (SME) in regulatory affairs, providing strategic direction and support to ensure compliance and successful project execution.

Key Responsibilities:

  • Lead and manage EU-MDR and global regulatory operations projects.
  • Serve as an internal consultant and advisor to the Program Manager on all regulatory affairs matters.
  • Support and manage EUDAMED related regulatory affairs activities.
  • Act as the SME for Summary Technical Documentation (STEDs) related to EU-MDR.
  • Provide expertise and support for R&D and regulatory affairs-related requests and strategies.
  • Support non-conformance (NC) and corrective and preventive actions (CAPA) with EU-MDR-related issues.
  • Conduct training sessions on internal regulatory affairs and EU-MDR topics.
  • Lead internal regulatory affairs project communication efforts.

Requirements

A completed degree in Engineering, Medical, or Science, or a related field. Minimum of 3 years of experience in Regulatory Affairs or Quality within the medical device industry, with specific management experience, ideally in a matrix organization. Proven experience in global project management and stakeholder management with Notified Bodies. Demonstrated experience in assembling and preparing regulatory submissions for medical devices. Experience in cross-functional team environments. Business-oriented mindset with a strong understanding of regulatory and quality management system (QMS) processes. Experience in managing regulatory projects in a global work environment. Exceptional written and verbal communication skills in English and conversational German are required.

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

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