Post Market Surveillance Manager

3 weeks ago


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

Oxford Nanopore Technologies is a leading company in the field of nanopore sequencing, with a strong presence in the UK and globally. We are seeking a highly skilled Post Market Surveillance Manager to join our team.

Key Responsibilities
  • Coordinate post-market surveillance activities in accordance with OND Quality Management System (QMS) policies and procedures.
  • Ensure that post-market surveillance plans for individual products are met.
  • Work closely with technical services and external partners to gather, triage, escalate, and complete PMS information.
  • Coordinate cross-functional teams to conduct investigations, gather information, analyze, and report on product field performance.
  • Provide information to the Regulatory Affairs Manager for vigilance reporting.
  • Educate staff on PMS requirements.
  • Work with the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes.
Requirements

We are looking for a candidate with a good grounding in IVD device regulations, specifically post-market surveillance requirements, with 3 or more years of experience working in a regulatory affairs team within the diagnostics industry.

A strong working knowledge of 21CFR, IVDR, and ISO 13485 is critical for this role.

The successful applicant will display key skills such as strong communications, excellent writing skills, effective team working, analytical/problem-solving skills, and persuasion skills.

What We Offer

We offer an attractive bonus, generous pension contributions, private healthcare, and an excellent starting salary.

Based within beautiful, landscaped surroundings with tree-lined walks, water features, and a lake, all of which make for a wonderful working environment.



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