Strategic Medical Devices Lifecycle Manager

2 weeks ago

Harefield, Greater London, United Kingdom Norgine Full time

About Norgine

Norgine is a leading healthcare organization that transforms lives with innovative healthcare solutions.

Job Summary

We are seeking an experienced Associate Director Medical Devices Lifecycle Management to join our Regulatory team. The successful candidate will be responsible for the strategic lifecycle management of Norgine's Medical Devices post CE approval and the operational execution management with the Regulatory Service Provider.

Key Responsibilities

  • Regulatory Expertise
    • Provide guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.
    • Input into discussions on projects and questions associated with medical devices.
    • Anticipate and resolve complex regulatory issues associated with medical devices.
  • Service Provider Management
    • Oversee, manage, and advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans, and the preparation of updates to the technical file and regulatory submissions for all medical device related changes.
    • Prepare high-quality documentation for labeling regulatory submissions, following current best practice.
    • Resolve roadblocks and escalate issues through effective communication.
  • Regulatory Affairs
    • 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.
    • Manage regulatory intelligence information for medical devices, including databases (e.g. NOTIS).
    • Coordinate QMS-related regulatory activities, e.g. deviations and CAPAs as applicable.
    • Explore opportunities for continuous improvement to enhance business performance.
    • Maintain data and documentation in compliance with Norgine's regulatory systems and procedures.
    • Participate in industry forums.
    • Ensure adherence to compliance policies.

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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