Post Market Surveillance Coordinator
2 months ago
Oxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. Our company is headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations.
We employ a diverse team of experts from various fields, including nanopore science, molecular biology, informatics, engineering, electronics, manufacturing, and commercialization. Our management team, led by CEO Dr. Gordon Sanghera, has a proven track record of delivering disruptive technologies to the market.
Job SummaryWe are seeking a highly skilled and experienced Post Market Surveillance Coordinator to join our Regulatory Affairs team. The successful candidate will be responsible for coordinating all post-market activities, ensuring compliance with regulatory requirements, and providing regular report updates to the Regulatory Affairs Manager and the wider business.
Key Responsibilities- Organize and 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 gathered, triaged, escalated, and completed appropriately.
- Coordinate cross-functional teams to ensure investigations, including 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.
- Create 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 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 communication, excellent writing skills, effective team working across multi-disciplinary teams, excellent analytical/problem-solving skills, strong persuasion skills, and the ability to make and take decisions, as well as understanding when to escalate.
What We OfferWe offer outstanding benefits, including an attractive bonus, generous pension contributions, private healthcare, and an excellent starting salary. Our company is based within beautiful, landscaped surroundings with tree-lined walks, water features, and a lake, making for a wonderful working environment.
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