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Post Market Surveillance Coordinator
2 months ago
Oxford Nanopore Technologies is a leading biotechnology company that specializes in the development 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.
Our sequencing platform is the only technology that offers real-time analysis, in fully scalable formats from pocket to population scale, that can analyze native DNA or RNA and sequence any length of fragment to achieve short to ultra-long read lengths. Our goal is to enable the analysis of any living thing, by anyone, anywhere.
Job SummaryWe are seeking a highly skilled Post Market Surveillance Coordinator to join our Regulatory Affairs team. The successful candidate will be responsible for coordinating all required post-market activities, ensuring that post-market surveillance tasks are aligned to our Quality Management System (QMS) policies, procedures, and international regulations.
Key Responsibilities- Organize and coordinate post-market surveillance tasks, ensuring compliance with QMS policies, procedures, and international regulations.
- Ensure that individual product Post Market Surveillance plans are met, and requirements are fulfilled.
- 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 conduct investigations, including detailed information gathering, analysis, and reporting.
- 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 possess strong communication, excellent writing skills, effective team working skills, excellent analytical/problem-solving skills, and strong persuasion skills, with the ability to make and take decisions and understand when to escalate.
What We OfferWe offer 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.
