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Post Market Surveillance Coordinator
2 months ago
Oxford Nanopore Technologies, headquartered at the Oxford Science Park, seeks a professional to oversee post-market surveillance activities for its sequencing platform. The role will coordinate tasks aligned to the company's Quality Management System (QMS) policies, procedures, and international regulations.
Key responsibilities include ensuring post-market surveillance plans for individual products are met, working closely with technical services and external partners to gather and report PMS information, and coordinating cross-functional teams for investigations. The successful candidate will have a strong grounding in IVD device regulations, specifically post-market surveillance requirements, and 3 or more years of experience in a regulatory affairs team within the diagnostics industry.
The ideal candidate will possess strong communication, writing, and analytical skills, as well as the ability to make and take decisions. A strong working knowledge of 21CFR, IVDR, and ISO 13485 is critical for the role. Oxford Nanopore offers an attractive bonus, generous pension contributions, private healthcare, and an excellent starting salary in a beautiful working environment.
In this role, you will contribute to the management review meetings through the preparation and presentation of PMS information. You will work alongside the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes and propose process enhancements where necessary.