Senior Regulatory Affairs Manager Medical Devices

3 settimane fa


Milano, Lombardia, Italia Cpl Healthcare A tempo pieno

Job Title: Associate Director, Regulatory Affairs Medical Device Lifecycle Management
Job Type: Full Time, Permanent Position
Location: Hybrid
Remuneration: Attractive salary and package

About the Role:

We are seeking a highly experienced Associate Director, Regulatory Affairs Medical Device Lifecycle Management to join our team. As a key member of our Regulatory Affairs department, you will be responsible for the strategic lifecycle management of our Medical Device portfolio post-CE approval. This includes:

  • Providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business
  • Leading and supporting all post-market surveillance activities for the Medical Device portfolio in the UK, Europe, and growth regions
  • Driving all Regulatory Affairs Medical Device strategies for global regions
  • Overseeing, managing, and advising 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

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 Us:

Cpl Healthcare is an exciting pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. We are looking for a talented individual to join our team and take responsibility for our growing portfolio of medical devices. This role offers an attractive salary and package and the opportunity to grow and develop with our company.

How to Apply:

Please contact us for more information regarding this role.



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