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Senior Regulatory Affairs Director

2 months ago

London, Greater London, United Kingdom Cpl Healthcare Full time

Job Title: Associate Director F/H

Job Type: Full Time, Permanent Position

Company: Cpl Healthcare

Job Description:

Job Summary:

We are seeking an experienced Associate Director to join our Regulatory Affairs team in a senior role. As an Associate Director, 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 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 associated with medical devices.
  • 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.
  • Oversee, manage, and where required 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.

Requirements:

  • 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.

About Us:

Cpl Healthcare is a leading healthcare recruitment agency, providing temporary and permanent staffing solutions to the healthcare industry. We are committed to delivering exceptional service and building long-term relationships with our clients and candidates.