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 across the US, APAC, and Europe.
We employ a diverse team of experts from multiple subject areas, including nanopore science, molecular biology, and applications, informatics, engineering, electronics, manufacturing, and commercialization. Our management team, led by CEO Dr. Gordon Sanghera, has a 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.
Key Responsibilities
- Coordinate all required post-market activities, ensuring compliance with regulatory requirements and company policies.
- Work closely with cross-functional teams to ensure investigations are conducted and concluded satisfactorily.
- Establish and maintain post-market surveillance 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 post-market surveillance activities.
- Work alongside the Regulatory Affairs Manager and Quality Assurance team to maintain post-market surveillance procedures and processes and propose process enhancements/improvements where necessary.
- Create post-market surveillance reports, with updates as required by those products' post-market surveillance plans.
- Contribute to management review meetings through preparation and presentation of post-market surveillance information.
Requirements
- Good grounding in IVD device regulations, specifically post-market surveillance requirements.
- 3 or more years of experience working in a regulatory affairs team within the diagnostics industry.
- Strong working knowledge of 21CFR, IVDR, and ISO 13485.
- Strong communications, excellent writing skills, effective team worker across multi-disciplinary teams, excellent analytical/problem-solving skills, and strong persuasion skills.
What We Offer
- Attractive bonus
- Generous pension contributions
- Private healthcare
- Excellent starting salary
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