Regulatory Affairs Director

hace 4 semanas

Zaragoza, Zaragoza, España Cpl Healthcare A tiempo completo

Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market Surveillance
Job Type: Full Time, Permanent Position
Locations: 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.

Main Responsibilities:

  • 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.
  • 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.
  • 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 practices.
  • Represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
  • 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.
  • Manage regulatory intelligence information for medical devices, including databases (e.g., NOTIS).
  • Coordinate QMS-related regulatory activities, e.g., deviations and CAPAs as applicable.
  • Manage your own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed, and progressed.

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 a sound understanding of new registrations and post-market surveillance activities.
  • Confident with maintaining medical devices in global regions.

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