Regulatory Affairs Director

hace 1 semana


Madrid, Madrid, España Cpl Healthcare A tiempo completo
Exciting Opportunity in Regulatory Affairs

Cpl Healthcare is seeking an experienced Regulatory Affairs Director to lead our medical device lifecycle management efforts. This is a full-time, permanent position based in Madrid, Spain.

About the Role

In this role, you will be responsible for strategic lifecycle management of our medical devices post-CE approval and operational execution management with our regulatory service provider. Your primary focus will be on ensuring compliance with regulatory requirements and providing guidance to internal teams.

Main Responsibilities
  • Lead and support all post-market surveillance activities for our medical device portfolio in the UK, Europe, and growth regions.
  • Drive all regulatory affairs strategies for global regions.
  • Oversight and advice to the regulatory service provider on medical device maintenance and submission strategies.
  • Prepare high-quality documentation for labeling regulatory submissions.
  • Represent the Regulatory Affairs Lifecycle Management – Medical Devices team internally and externally.
Requirements

To succeed in this role, you will need:

  • At least 8 years of experience in Regulatory Affairs within the medical device sector.
  • A sound understanding of new registrations and post-market surveillance activities.
  • Confident management of medical devices in global regions.
What We Offer

We offer a competitive salary of €80,000 - €100,000 per annum, depending on experience. You will also receive a comprehensive benefits package, including health insurance, retirement plan, and professional development opportunities.



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