Regulatory Affairs Specialist

3 weeks ago

London, Greater London, United Kingdom G&L Healthcare Advisors Full time
Job Title: Regulatory Affairs Manager

We are seeking a highly skilled Regulatory Affairs Manager to join our team at G&L Healthcare Advisors. As a key member of our international team, you will be responsible for providing expert guidance and support across a variety of medical devices and combination products.

About the Role:

This is an exciting opportunity for a senior consultant to lead regulatory strategy and submission processes for medical devices and combination products, ensuring compliance with MDR, IVDR, and other relevant regulations. You will work closely with cross-functional teams, including R&D, Quality Assurance, and Marketing, to provide strategic regulatory input.

Key Responsibilities:
  • Develop and implement regulatory strategies for medical devices and combination products.
  • Prepare and submit regulatory dossiers for combination products that incorporate both medical devices and pharmaceuticals.
  • Ensure compliance with global regulatory frameworks, including FDA, EMA, and other international markets.
  • Provide guidance on post-market surveillance and risk management requirements for medical devices.
  • Collaborate with cross-functional teams to provide strategic regulatory input.
  • Stay updated on the latest changes in global regulations, ensuring that all client projects meet evolving compliance standards.
Requirements:
  • Minimum 5 years of experience in Regulatory Affairs, specifically in the medical device industry.
  • Strong knowledge of MDR, IVDR, and experience with FDA submissions.
  • Experience with combination products and companion diagnostics.
  • Understanding of LIMS regulatory requirements and validation processes.
  • Familiarity with regulatory compliance for various medical device types (Class I, II, III).
  • Excellent project management skills and ability to juggle multiple projects with competing priorities.
  • Ability to provide clear and actionable regulatory advice across different stages of product development.
  • Strong written and verbal communication skills, with a collaborative approach to working with diverse teams and clients.
What We Offer:
  • Opportunity to work on cutting-edge medical device projects across diverse fields.
  • Collaborative and innovative environment with opportunities for professional growth.
  • Competitive salary and benefits package.
  • Flexible working arrangements (remote/hybrid).

If you are a highly skilled and versatile Regulatory Affairs professional looking for an exciting role with diverse challenges, we would love to hear from you.

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