Regulatory Affairs Director

3 settimane fa

Milano, Lombardia, Italia Cpl Healthcare A tempo pieno

Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance

Job Type: Full Time, Permanent Position

Location: Hybrid

Remuneration: Attractive salary and package

Cpl Healthcare is seeking an experienced Associate Director, Regulatory Affairs - Medical Device Lifecycle Management to join their team. This role offers a unique opportunity to take responsibility for the strategic lifecycle management of medical devices and drive regulatory affairs strategies for global regions.

Main Responsibilities:

  1. Provide guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.
  2. Lead and support all post-market surveillance activities for the medical device portfolio in the UK, Europe, and growth regions.
  3. Drive all Regulatory Affairs Medical Device strategies for global regions.
  4. 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.
  5. Prepare high-quality documentation for labeling regulatory submissions, following current best practices.
  6. Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
  7. Maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards and apply them in practice through procedures, knowledge sharing, and advice to project teams.
  8. Manage regulatory intelligence information for medical devices, including databases.
  9. Coordinate QMS-related regulatory activities, e.g., deviations and CAPAs as applicable.
  10. Manage your own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed, and progressed.

Requirements:

  1. BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
  2. Previous experience in Regulatory Affairs is a MUST.
  3. At least 8 years of experience within the medical device sector and sound understanding of new registrations and post-market surveillance activities.
  4. Confident with maintaining medical devices in global regions.
  5. Broad regulatory medical device experience, part of which should have been gained operating at a senior level, and good knowledge of worldwide regulatory requirements.
  6. Must have expertise in the development, certification, and maintenance of medical device products.
  7. Line management or staff oversight/coaching experience.
  8. Experience managing Service Providers is essential.

This role offers a unique opportunity to take responsibility for the strategic lifecycle management of medical devices and drive regulatory affairs strategies for global regions. If you are an experienced Regulatory Affairs professional looking for a new challenge, please apply.

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