Post-Market Surveillance Lead
3 weeks ago
About Oxford Nanopore Technologies
Oxford Nanopore Technologies is a pioneering company at the forefront of genomic analysis, with a commitment to innovation and excellence in the field of life sciences.
Our headquarters are located in a dynamic environment, and we have a presence in various global markets, including the US, APAC, and Europe. Our team is composed of experts from diverse fields such as nanopore technology, molecular biology, engineering, and commercialisation.
Role Overview
We are seeking a dedicated Post-Market Surveillance Lead to join our Regulatory Affairs team. This position will report directly to the Regulatory Affairs Manager and will play a crucial role in coordinating all necessary post-market activities. You will ensure that our post-market surveillance initiatives align with the OND Quality Management System (QMS) and comply with regulatory reporting timelines.
Key Responsibilities
- Coordinate and manage post-market surveillance tasks in accordance with OND QMS policies and international regulations.
- Ensure compliance with the post-market surveillance plans for individual products.
- Collaborate with technical services and strategic partners to gather and manage PMS information effectively.
- Lead cross-functional teams to conduct thorough investigations, including data collection, analysis, and reporting.
- Work closely with the Regulatory Affairs Manager to establish and maintain PMS information sources for customer feedback and product performance monitoring.
- Provide timely information to assist in the development of vigilance reporting.
- Educate team members on post-market surveillance requirements and best practices.
- Collaborate with the Quality Assurance team to enhance PMS procedures and processes.
- Prepare and update PMS reports as necessary.
- Contribute to management review meetings by presenting PMS information.
Qualifications
The ideal candidate will possess a solid understanding of IVD device regulations, particularly in post-market surveillance, with a minimum of three years of experience in a regulatory affairs capacity within the diagnostics sector. A strong grasp of 21CFR, IVDR, and ISO 13485 is essential.
Key skills include:
- Exceptional communication and writing abilities.
- Proven ability to work effectively within multidisciplinary teams.
- Strong analytical and problem-solving skills.
- Persuasive communication skills with sound decision-making capabilities.
What We Offer
We provide a comprehensive benefits package, including a competitive bonus structure, generous pension contributions, and private healthcare. Our work environment is designed to be inspiring and conducive to productivity, surrounded by beautiful landscaping and serene features.
If you are passionate about making a significant impact in the field of genomics, we encourage you to consider this opportunity.
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