Regulatory Affairs Director

5 days ago

London, Greater London, United Kingdom Cpl Healthcare Full time

Job Title: Regulatory Affairs Director - Medical Devices

Job Type: Full Time, Permanent Position

Location: Remote or On-Site

Remuneration: Attractive salary and package

Cpl Healthcare is seeking a highly experienced Regulatory Affairs Director to join our team. As a key member of our Medical Devices department, you will be responsible for the strategic lifecycle management of our medical devices post CE approval.

Main Responsibilities:

  • 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, anticipating and resolving complex regulatory issues.
  • Lead and support all post-market surveillance activities for the medical device portfolio in the UK, Europe, and growth regions.
  • Drive all Regulatory Affairs Medical Device strategies for global regions.
  • Responsible for NPD activities for devices.
  • 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.
  • Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
  • 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.
  • Coordinate QMS-related regulatory activities, e.g., deviations and CAPAs as applicable.

Requirements:

  • BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
  • Previous experience in Regulatory Affairs is a MUST.
  • At least 8 years + experience within the medical device sector and have a sound understanding of new registrations and post-market surveillance activities.
  • Confident with maintaining medical devices in global regions.
  • 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.

This role offers a unique opportunity to join a growing pharmaceutical company and take responsibility for a growing portfolio of medical devices. The position comes with an attractive salary and package.

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