Regulatory Affairs Manager

1 month ago


Oxford, Oxfordshire, United Kingdom OrganOx Full time

OrganOx is a pioneering medical device company that's transforming the field of organ transplantation. We're looking for a talented Regulatory Affairs Manager - Complaints to join our dynamic team.

In this role, you'll be responsible for managing regulatory activities, reporting directly to the Global Director RA/QA. Your primary focus will be on ensuring compliance with reporting and complaints procedures, receiving and reviewing customer, internal, and feedback complaints within regulatory timeframes.

  • You'll also be responsible for 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.
  • Additionally, you'll work closely with cross-functional teams to identify and implement process improvements, ensuring seamless integration with existing systems and processes.

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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