Post Market Surveillance Manager

4 weeks ago


Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time
About the Role

Oxford Nanopore Technologies is a leading innovator in the field of nanopore sequencing, with a mission to enable the analysis of any living thing, by anyone, anywhere. We are seeking a highly skilled Post Market Surveillance Manager to join our team, responsible for ensuring the quality and safety of our products.

Key Responsibilities
  • Coordinate post-market surveillance activities in accordance with our Quality Management System (QMS) and international regulations.
  • Ensure that post-market surveillance plans are implemented and completed according to defined timelines.
  • Collaborate with cross-functional teams to investigate and resolve product-related issues.
  • Develop and maintain post-market surveillance information sources to gather customer feedback and monitor product performance.
  • Provide regular updates to the Regulatory Affairs Manager and Quality Assurance team.
Requirements

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

A strong understanding of 21CFR, IVDR, and ISO 13485 is essential for this role. The successful candidate will possess excellent communication, writing, and analytical skills, as well as the ability to work effectively in a team environment.

What We Offer

Oxford Nanopore Technologies offers a competitive salary, attractive bonus, generous pension contributions, and private healthcare. Our beautiful, landscaped surroundings provide a wonderful working environment, with tree-lined walks, water features, and a lake.



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