Regulatory Affairs Specialist

4 weeks ago

London, Greater London, United Kingdom G&L Healthcare Advisors Full time
Senior Consultant in Medical Devices

G&L Healthcare Advisors is a leading provider of Regulatory Affairs and Quality Assurance consultancy services to the healthcare industry. We are seeking a highly skilled Senior Consultant in Medical Devices to join our international team of experienced Regulatory professionals.

The ideal candidate will have a strong understanding of regulatory compliance for various medical device types, including Class I, II, and III. They will be responsible for leading regulatory strategy and submission processes, ensuring compliance with MDR, IVDR, and other relevant regulations.

Key responsibilities will include:

  • Leading regulatory efforts in product lifecycle management, from R&D through to commercialization
  • Collaborating with cross-functional teams to provide strategic regulatory input
  • Staying updated on the latest changes in global regulations
  • Providing guidance on post-market surveillance and risk management requirements
  • Preparing and submitting regulatory dossiers for combination products

The successful candidate will have a minimum of 5 years of experience in Regulatory Affairs, specifically in the medical device industry. They will be familiar with LIMS regulatory requirements and validation processes, and have excellent project management skills.

We offer a competitive salary and benefits package, flexible working arrangements, and the opportunity to work on cutting-edge medical device projects across diverse fields. 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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