Head of Regulatory and Quality Systems

2 days ago


Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

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
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
Salary Range:

We are offering a competitive salary range of £80,000 - £110,000 per annum, depending on experience.



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