Regulatory Affairs Director

2 weeks ago


Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

Oxford Nanopore Technologies is a leading developer of innovative sequencing technologies. As a key member of our team, you will play a critical role in ensuring the company's products meet the highest regulatory standards.

Key Responsibilities
  • Manage the Regulatory, Risk Management, PMS and Clinical Affairs functions to ensure compliance with regulatory requirements.
  • Establish strong working relationships across the business to facilitate best practices in risk management, product development, testing, manufacture and post-market surveillance.
  • Provide regulatory input into the development and maintenance of Quality Systems to ensure compliance with regulatory requirements.
  • Ensure the business is updated with regulatory expectations and intelligence.

Qualifications include a BSc level or higher in a relevant scientific subject area or proven experience in a relevant regulatory role. A minimum of 5 years' experience in a senior regulatory management role in the IVD industry is required, with management responsibility for a team of >5.



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