Medical Devices Lifecycle Management Director

15 hours ago


Copenhagen, Copenhagen, Denmark Internetwork Expert Full time
Transform Lives with Innovative Healthcare Solutions

We are seeking an experienced Associate Director Medical Devices Lifecycle Management to join our Regulatory team at Norgine. As a key member of our team, you will be responsible for the strategic lifecycle management of our Medical Devices post CE approval and the operational execution management with our Regulatory Service Provider.

Key Responsibilities:
  • Provide regulatory guidance and support to brand teams and other areas of the business on medical device requirements and compliance.
  • Oversee and manage the Regulatory Service Provider on medical device maintenance and submission strategies, plans, and documentation.
  • Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
  • Manage own workload and ensure agreed regulatory activities are planned, agreed, and progressed.
  • Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards.
Requirements:
  • BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
  • Broad regulatory medical device experience, part of which should have been gained operating at a senior level, and good knowledge of worldwide regulatory requirements.
  • Expertise in the development, certification, and maintenance of medical device products.
  • Line management or staff oversight/coaching experience.
  • Experience managing Service Providers is essential.


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