Regulatory Compliance Manager
24 hours ago
Job Description
Oxford Nanopore Technologies is a leading company in the field of genetic analysis, headquartered in the UK with satellite offices and commercial presence in multiple locations globally.
We are seeking a Regulatory Compliance Manager to join our team. This role will be responsible for coordinating post-market activities across the organization, ensuring compliance with regulatory requirements and international standards. You will work closely with our Regulatory Affairs Manager and Quality Assurance team to maintain procedures and processes, propose enhancements, and contribute to management review meetings.
The successful applicant will have a good grounding in IVD device regulations, specifically post-market surveillance requirements, with several years' experience working in a regulatory affairs team within the diagnostics industry. You will display key skills such as strong communication, excellent writing skills, effective team worker, and analytical/problem-solving skills.
Key responsibilities include:
- Coordinating cross-functional teams to ensure investigations are conducted and concluded satisfactorily.
- Working with the Regulatory Affairs Manager to establish and maintain PMS information sources for actively gathering customer feedback and monitoring product field performance.
- Providing information in a timely manner to the Regulatory Affairs Manager for use in the development of vigilance reporting.
We offer a competitive salary range of £60,000 - £80,000 per annum, depending on experience, along with benefits that include pension scheme, life insurance, and annual leave entitlement. If you are a motivated individual with a passion for regulatory compliance, we encourage you to apply for this exciting opportunity.
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