Regulatory Compliance Specialist
1 month ago
Oxford Nanopore Technologies, a leading company in the diagnostics industry, is seeking a Regulatory Compliance Specialist to join their team. This role will be responsible for coordinating all required post-market activities, ensuring compliance with international regulations and OND Quality Management System (QMS) policies.
The successful applicant will have a good grounding in IVD device regulations, specifically post-market surveillance requirements, and several years' experience working in a regulatory affairs team within the diagnostics industry.
Key Responsibilities:
- Organise and coordinate post-market surveillance tasks aligned to OND QMS policies and procedures.
- Work closely with technical services and external partners to ensure PMS information is captured, triaged, escalated, and completed appropriately.
- Conduct investigations, including detailed information gathering, analysis, and reporting.
- Maintain PMS information sources for gathering customer feedback, monitoring, and reporting of product field performance.
- Provide timely information to the Regulatory Affairs Manager for vigilance reporting.
- Collaborate with the Regulatory Affairs Manager and Quality Assurance team to maintain PMS procedures and processes.
- Contribute to management review meetings through PMS information preparation and presentation.
Salary: The estimated salary for this role is £60,000 - £80,000 per annum, depending on experience.
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