Regulatory Affairs Director

1 month ago


Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full time

About Us

Oxford Nanopore Technologies is a leading company in the field of sequencing technology, with a presence in multiple global locations. The company employs experts from various fields, including nanopore science, molecular biology, and informatics.

The Senior Director of Regulatory Affairs will be responsible for ensuring the company's compliance with regulatory requirements, overseeing the Regulatory Affairs team, and ensuring the quality management system is in place.

  • The postholder will manage the Regulatory, Risk Management, PMS, and Clinical Affairs functions, conducting a wide range of duties to ensure compliance with regulatory obligations.
  • The postholder will have the authority to review and approve product regulatory processes, documents, and records.
  • The postholder will establish strong working relationships across the business to facilitate best practices in risk management, product development, testing, manufacture, and post-market surveillance.
  • The postholder will regularly monitor data outputs from functions with regulatory relevance, such as complaints and customer feedback.
  • The postholder will provide regulatory input into the development and maintenance of Quality Systems to ensure compliance with regulatory requirements.
  • The postholder will ensure the business is updated with regulatory expectations and intelligence.
  • The postholder will ensure training on regulatory processes is developed and maintained and assigned appropriately.
  • The postholder will establish and maintain an effective Post Market Surveillance system to meet regulatory requirements.
  • The postholder will provide regulatory support to internal and external audits and inspections.
  • The postholder will support and progress the compilation of regulatory submissions.
  • The postholder will provide regulatory support in the correct application of technical standards to meet regulatory requirements and industry best practices.

Qualifications/Experience:

  • Qualification to BSc level or higher in a relevant scientific subject area or proven experience in working in a relevant regulatory role.
  • 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, electrotechnical instrumentation compliance, and IVD V&V standards.
  • Strong working knowledge of regulatory requirements applicable to IVD devices.
  • Hands-on experience with leading teams to achieving compliance to at least two of the following:


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