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Vigilance and Post Market Surveillance Manager
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Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout the RoleOxford Nanopore Technologies is a leading company in the field of nanopore sequencing, with a strong presence in the global market. We are seeking a highly skilled and experienced individual to join our team as a Vigilance and Post Market Surveillance Manager.Key ResponsibilitiesCoordinate post-market surveillance activities in accordance with...
Post Market Surveillance Manager
4 weeks ago
Oxford Nanopore Technologies is a leading company in the field of nanopore sequencing, with a strong presence in the global market. We are seeking a highly skilled and experienced individual to join our team as a Vigilance & Post Market Surveillance Manager.
Job Summary:
The successful candidate will be responsible for coordinating all post-market activities, ensuring compliance with regulatory requirements and company policies. This role will involve working closely with various departments to ensure that post-market surveillance activities are applied and completed according to defined regulatory reporting timelines.
Key Responsibilities:
- Organize and coordinate post-market surveillance tasks aligned to OND QMS policies, procedures, processes, and international regulations.
- Ensure that the requirements of individual products Post Market Surveillance plans are met.
- Collaborate with OND technical services and external key strategic partners to ensure PMS information is captured, triaged, escalated, and completed appropriately.
- Coordinate cross-functional teams to ensure investigations that include detailed information gathering, analysis, and reporting are conducted and concluded satisfactorily.
- Work with the Regulatory Affairs Manager to establish and maintain PMS information sources for actively gathering customer feedback, monitoring, and reporting of product field performance.
- Provide information in a timely manner to the Regulatory Affairs Manager for use in the development of any required vigilance reporting.
- Educate other members of staff in the requirements of PMS activities.
- Work alongside the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes and propose process enhancement/improvements where necessary.
- Build PMS reports, with updates as required by those products PMS plans.
- Contribute to management review meetings through preparation and presentation of PMS information.
Requirements:
We are looking for a highly skilled and experienced individual with a good grounding in IVD device regulations, specifically post-market surveillance requirements. The successful candidate will have several years' 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.
What We Offer:
Oxford Nanopore Technologies offers a competitive salary, attractive bonus, generous pension contributions, private healthcare, and an excellent working environment. If you are looking to utilize your skills to make a difference in the field of nanopore sequencing, we encourage you to apply today.
