Market Surveillance and Compliance Manager

3 weeks ago

Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time
Job Title: Market Monitoring and Surveillance Manager

Oxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with a global presence across the US, APAC, and Europe. We are seeking a highly skilled Market Monitoring and Surveillance Manager to join our Regulatory Affairs team.

Job Summary:

This role will be responsible for coordinating all post-market activities, ensuring compliance with regulatory requirements and company policies. The successful candidate will work closely with cross-functional teams to gather customer feedback, monitor product field performance, and report on any vigilance issues.

Key Responsibilities:
  • Coordinate post-market surveillance tasks aligned to OND QMS policies and international regulations
  • Work closely with OND technical services and external partners to ensure PMS information is captured, triaged, escalated, and completed appropriately
  • Collaborate with cross-functional teams to conduct investigations, gather information, analyze data, and report on findings
  • Establish and maintain PMS information sources for actively gathering customer feedback and monitoring product field performance
  • Provide timely information to the Regulatory Affairs Manager for use in vigilance reporting
  • Maintain PMS procedures and processes, proposing enhancements and improvements as necessary
Requirements:

We are looking for a highly skilled and experienced professional with a good grounding in IVD device regulations, specifically post-market surveillance requirements. The successful candidate will have several years' experience working in a regulatory affairs team within the diagnostics industry.

The ideal candidate will possess strong communication and writing skills, effective team working skills, excellent analytical and problem-solving skills, and strong persuasion skills. They will also be able to make and take decisions, understanding when to escalate issues.

Oxford Nanopore Technologies is an equal opportunities employer and welcomes applications from all qualified candidates.

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