Post Market Surveillance Manager
1 month ago
Oxford Nanopore Technologies is a leading biotechnology company that is revolutionizing the field of genomics. We are seeking a highly skilled and experienced Post Market Surveillance Manager to join our team.
The successful candidate will be responsible for ensuring that our products meet the highest standards of quality and safety. This will involve coordinating post-market surveillance activities, working closely with our technical services and external partners, and collaborating with cross-functional teams to investigate and resolve any issues that may arise.
Key Responsibilities- Coordinate post-market surveillance tasks aligned to our Quality Management System (QMS) policies, procedures, and international regulations.
- Ensure that the requirements of individual products' Post Market Surveillance plans are met.
- Work closely with our 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 enhancements/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.
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. The ideal candidate will also have excellent communication, writing, and analytical skills, as well as the ability to work effectively in a team environment.
What We OfferWe offer a competitive salary, excellent benefits, and a wonderful working environment. If you are looking for a challenging and rewarding role that will allow you to make a real difference, then we encourage you to apply.
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Post Market Surveillance Manager
4 weeks ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout the RoleOxford Nanopore Technologies is a leading innovator in the field of DNA sequencing, with a mission to enable the analysis of any living thing, by anyone, anywhere. We are seeking a highly skilled Post Market Surveillance Manager to join our team, responsible for ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate...
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Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout the RoleOxford Nanopore Technologies is a leading innovator in the field of nanopore sequencing, with a mission to enable the analysis of any living thing, by anyone, anywhere. We are seeking a highly skilled Post Market Surveillance Manager to join our team, responsible for ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate...
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Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout the RoleOxford Nanopore Technologies is a leading innovator in the field of nanopore sequencing, with a mission to enable the analysis of any living thing, by anyone, anywhere. We are seeking a highly skilled Post Market Surveillance Manager to join our team, responsible for ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate...
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