Head of Regulatory and Quality Systems
2 days ago
Oxford Nanopore Technologies is committed to advancing the field of sequencing technologies. As Senior Director Regulatory Affairs, you will have the opportunity to work with a talented team of professionals who share your passion for innovation and excellence.
About the Team:Our team is dedicated to ensuring the firm's products meet the highest standards of quality and safety. We are looking for a seasoned regulatory professional who can bring their expertise and experience to help drive our regulatory strategy forward.
Key Responsibilities:- Conduct regular audits and inspections to ensure compliance with regulatory requirements
- Provide regulatory input into the development and maintenance of Quality Systems
- Establish and maintain an effective Post Market Surveillance system to meet regulatory requirements
- A minimum of 5 years' experience in a senior regulatory management role (with significant quality contribution/responsibility) in the IVD industry, with management responsibility for a team of >5
- Detailed understanding of risk management, process validation, clinical validation and IVD performance evaluation requirements
- A BSc degree or higher in a relevant scientific subject area or proven experience in working in a relevant regulatory role
We are offering a competitive salary range of £80,000 - £110,000 per annum, depending on experience.
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Director of Quality and Regulatory
1 week ago
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Regulatory Compliance Specialist
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