Medical Devices Lifecycle Management Director
3 weeks ago
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 preparation of updates to the technical file and regulatory submissions.
- Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
- Manage own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed, and progressed.
- Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards and apply in practice through procedures, knowledge sharing, and advice to project teams.
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 (including GMP, GLP, and BCP).
- Must have 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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