Post Market Surveillance Coordinator

4 weeks ago


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

Oxford Nanopore Technologies is a leading biotechnology company that is revolutionizing the field of genomics. We are seeking a highly skilled Post Market Surveillance Manager to join our team.

About the Role

This is an exciting opportunity to work in a dynamic and innovative company that is pushing the boundaries of what is possible in the field of genomics. As a Post Market Surveillance Manager, you will be responsible for ensuring that our products meet the highest standards of quality and safety.

Key Responsibilities
  • Coordinate post-market surveillance activities in accordance with our Quality Management System (QMS) policies and procedures.
  • Work closely with our Regulatory Affairs team to ensure that all regulatory requirements are met.
  • Develop and implement post-market surveillance plans for our products.
  • Collaborate with our technical services team to gather and analyze data on product performance.
  • Provide regular updates to our Regulatory Affairs Manager and other stakeholders on post-market surveillance activities.
Requirements

We are looking for a highly skilled and experienced professional who has a strong understanding of post-market surveillance regulations and quality management systems. You will have a good grounding in IVD device regulations, specifically post-market surveillance requirements, and 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 essential for this role. You will also have excellent communication and analytical skills, as well as the ability to work effectively in a team environment.

What We Offer

We offer a competitive salary and benefits package, as well as the opportunity to work in a dynamic and innovative company that is making a real difference in the field of genomics. If you are a motivated and experienced professional who is looking for a new challenge, we would love to hear from you.



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