Senior Compliance Specialist

15 hours ago


Belfast, United Kingdom ARC Regulatory Ltd Full time

Are you a seasoned professional looking for a new challenge? We have an exciting opportunity for a Senior Compliance Specialist - Medical Devices to join our team at ARC Regulatory Ltd.

We offer a competitive salary range of £55,000 - £75,000 per annum, depending on experience and location.

Job Summary:

This role will involve providing regulatory expertise to support the development and delivery of global compliance solutions to client companies. You will work closely with our project teams to ensure that client objectives are met and exceeded at all times.

Key Responsibilities:
  1. Develop and implement global regulatory strategies for IVD devices
  2. Prepare and submit regulatory documents, including IVDR Annex XIV applications, CTAs, study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
  3. Manage and maintain information relating to global regulatory requirements for IVD devices


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