Medical Device Specialist

2 weeks ago


Belfast, United Kingdom ARC Regulatory Ltd Full time
Job Summary

We are looking for a skilled Medical Device Specialist to join our team at ARC Regulatory Ltd. As a Senior Specialist in Regulatory Affairs, you will be responsible for developing and implementing global regulatory strategies for IVD devices, ensuring compliance with key global markets.

About You
  • You have an engineering or scientific honours degree or equivalent (10+ years) relevant industry experience.
  • You have 5+ years experience of working in a medical device/IVD manufacturing or regulatory environment.
  • You have knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices.
Key Responsibilities
  • Research and prepare elements of regulatory submission documents, including IVDR Annex XIV applications, CTAs, and IDE submissions.
  • Develop and implement global regulatory strategies for IVD devices, ensuring compliance with key global markets.
  • Collaborate with cross-functional teams to develop and deliver formal client presentations and training sessions.
Benefits
  • Competitive salary: £60,000 - £80,000 per annum.
  • Opportunities for professional development and continuing education.


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