Associate Director, Regulatory Affairs

hace 2 meses

Madrid, España Cpl Healthcare A tiempo completo

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

Job Type: Full Time, Permanent Position

Location: Spain, Madrid – Hybrid

Remuneration: Attractive salary and package

An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to increasing growth, the business is looking for an Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join the team.

As an Associate Director, Regulatory Affairs - Medical Devices Lifecycle Management, you will be responsible for the strategic lifecycle management of the business's Medical Device post CE approval and the operational execution management with the Regulatory Service Provider. This includes the responsibility and oversight of all activities required for the successful and smooth integration of new products following launch and all associated ongoing regulatory maintenance activities.

Main Responsibilities:

  1. Be the primary regulatory point of contact for all medical device queries for the business's portfolio by providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.
  2. Input into discussions on projects and questions associated with medical devices, anticipating and resolving complex regulatory issues.
  3. Lead and support all post-market surveillance activities for the medical device portfolio in the UK, Europe, and growth regions.
  4. Drive all Regulatory Affairs Medical Device strategies for global regions.
  5. Oversee, manage, and advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans, and preparation of updates to the technical file and regulatory submissions for all medical device-related changes.
  6. Prepare high-quality documentation for labeling regulatory submissions, following current best practices.
  7. Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
  8. 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.
  9. Manage regulatory intelligence information for medical devices including databases (e.g., NOTIS).
  10. Coordinate QMS-related regulatory activities e.g., deviations and CAPAs as applicable.
  11. Manage 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 + experience within the medical device sector with a 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 (including GMP, GLP, and BCP).
  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 allows the right person to step into a senior role within the business and take responsibility for a growing portfolio of medical devices. Due to the business's continuous growth, this person will have an excellent opportunity to grow and develop. The position also comes with an attractive salary and package.

Please note you must have the full right to work, and this employer doesn’t offer sponsorship.

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