Post Market Surveillance Coordinator

6 days ago

Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

Oxford Nanopore Technologies is a leading company in the field of sequencing technologies, with a presence in multiple global locations. We are seeking a highly skilled individual to join our team as a Post Market Surveillance Manager.

The successful candidate will be responsible for coordinating post-market activities, ensuring compliance with regulatory requirements, and providing regular report updates to the regulatory affairs manager and the wider business.

The key responsibilities of this role include:

  • Organising and coordinating post-market surveillance tasks aligned to OND QMS policies, procedures, processes, and international regulations.
  • Ensuring that the requirements of individual products Post Market Surveillance plans are met.
  • Working closely with OND technical services and external key strategic partners to ensure PMS information is gathered, triaged, escalated, and completed appropriately.
  • Coordinating cross-functional teams to ensure investigations that include detailed information gathering, analysis, and reporting are conducted and concluded satisfactorily.
  • Working with the Regulatory Affairs Manager, establishing and maintaining PMS information sources for actively gathering customer feedback, monitoring, and reporting of product field performance.
  • Providing information in a timely manner to the Regulatory Affairs Manager for use in the development of any required vigilance reporting.
  • Educating other members of staff in the requirements of PMS activities.
  • Working alongside the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes and propose process enhancement/improvements where necessary.
  • Creating PMS reports, with updates as required by those products PMS plans.
  • Contributing to management review meetings through preparation and presentation of PMS information.

We are looking for a candidate with 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 critical for this role.

The successful applicant will display key skills such as strong communications, 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 but also understanding of when to escalate.

We offer outstanding benefits, including an attractive bonus, generous pension contributions, private healthcare, and an excellent starting salary. Based within beautiful, landscaped surroundings, we provide a wonderful working environment.

If you are looking to utilise your skills to make a difference to humankind, then consider joining our team and apply today.

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