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Market Monitoring and Surveillance Coordinator

2 months ago


Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time
Job Description

Oxford Nanopore Technologies is a leading biotechnology company headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations across the US, APAC, and Europe.

The company employs experts from multiple subject areas, including nanopore science, molecular biology, and applications, informatics, engineering, electronics, manufacturing, and commercialization. The management team, led by CEO Dr. Gordon Sanghera, has a track record of delivering disruptive technologies to the market.

Job Summary

This role will be responsible for the coordination of all required post-market activities, working closely with the Regulatory Affairs Manager and cross-functional teams to ensure compliance with regulatory requirements.

Key Responsibilities
  • Organize and coordinate post-market surveillance tasks aligned to OND QMS policies, procedures, processes, and international regulations.
  • Work closely with OND technical services and external key strategic partners to ensure PMS information is captured, triaged, escalated, and completed appropriately.
  • Coordinate cross-functional teams to ensure investigations that include detailed information gathering, analysis, and reporting are conducted and concluded satisfactorily.
  • Establish and maintain PMS information sources for actively gathering customer feedback, monitoring, and reporting of product field performance.
  • Provide information in a timely manner to the Regulatory Affairs Manager for use in the development of any required vigilance reporting.
  • Work alongside the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes and propose process enhancement/improvements where necessary.
  • Contribute to management review meetings through preparation and presentation of PMS information.
Requirements

We are looking for a candidate with a good grounding in IVD device regulations, specifically post-market surveillance requirements, with several years' experience working in a regulatory affairs team within the diagnostics industry.

The successful applicant will display key skills such as strong communication, excellent writing skills, effective team worker across multi-disciplinary teams, excellent analytical/problem-solving skills, strong persuasion skills, and the ability to make and take decisions, as well as understanding when to escalate.

What We Offer

We offer outstanding benefits, including an attractive bonus, generous pension contributions, private healthcare, and an excellent starting salary. Our beautiful, landscaped surroundings with tree-lined walks, water features, and a lake make for a wonderful working environment.