Medical Device Compliance Specialist

3 days ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time

At OrganOx, we're revolutionizing organ transplantation with our cutting-edge normothermic machine perfusion technology. Our team is dedicated to preserving donor livers for up to 24 hours, reducing discard rates and improving transplants.

We're seeking a highly motivated Medical Device Compliance Specialist to join our fast-paced medical device company. As a key member of the regulatory affairs team, you will be responsible for managing regulatory activities, reporting directly to the Global Director RA/QA.

  • You will ensure compliance with reporting and complaints procedures, receiving and reviewing customer, internal, and feedback complaints within regulatory timeframes.
  • Your key responsibilities include reporting complaints, including vigilance and medical device reporting, managing field safety corrective actions and notices, collaborating on annual and post-market reports, trending for management review meetings, leading nonconformity and design change teams, and providing customer updates on complaint status.

Requirements:

  • At least 3 years' experience within the NHS
  • Full training provided

We offer a competitive salary of £45,000 - £60,000 per annum, depending on experience, plus a range of benefits, including comprehensive health insurance and generous paid leave.

We are an equal opportunity employer, committed to diversity and inclusion.



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