Senior Regulatory Affairs Expert

3 settimane fa

Milano, Lombardia, Italia Cpl Healthcare A tempo pieno
Job Title: Associate Director, Regulatory Affairs - Medical Device/Post Market Surveillance

About the Role:
As a key member of our Regulatory Affairs team, you will be responsible for the strategic lifecycle management of our Medical Devices. This includes 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:
  • Be the primary regulatory point of contact for all medical device queries, providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.
  • 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 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.

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 of experience within the medical device sector and 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.

About Cpl Healthcare:
Cpl Healthcare is a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. We are committed to delivering high-quality medical devices and services to our customers. This role offers an exciting opportunity to join our team and take responsibility for a growing portfolio of medical devices. If you are a highly motivated and experienced Regulatory Affairs professional, we encourage you to apply for this challenging and rewarding role.

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