Regulatory Affairs Director

1 week ago

Oxford, Oxfordshire, United Kingdom https:jobs-redefined.cositemap Full time
Senior Director Regulatory Affairs

Oxford Nanopore Technologies is a leading developer of nanopore-based next-generation sequencing technology. The company is headquartered in the UK and has a global presence with offices and commercial operations in multiple locations across the US, APAC, and Europe.

The Senior Director Regulatory Affairs will be responsible for ensuring the company's compliance with regulatory obligations, overseeing the Regulatory Affairs team, and ensuring compliance with the Quality Management System (QMS). The role will involve managing the Regulatory, Risk Management, Product Management, and Clinical Affairs functions, as well as conducting a wide range of duties to ensure that both Oxford Nanopore Diagnostics and Oxford Nanopore Technologies meet their regulatory obligations.

The ideal candidate will have a strong understanding of risk management, process validation, clinical validation, and IVD performance evaluation requirements. They will also have a minimum of 5 years' experience in a senior regulatory management role in the IVD industry, with management responsibility for a team of >5.

Key Responsibilities:

  • Manage the Regulatory, Risk Management, Product Management, and Clinical Affairs functions
  • Establish strong working relationships across the business to facilitate best practices in risk management, product development, testing, manufacture, and post-market surveillance
  • Regularly monitor data outputs from functions with regulatory relevance
  • Provide regulatory input into the development and maintenance of Quality Systems
  • Ensure the business is updated with regulatory expectations and intelligence
  • Establish and maintain an effective Post-Market Surveillance system
  • Provide regulatory support to internal and external audits and inspections
  • Support and progress the compilation of regulatory submissions

Requirements:

  • Qualification to BSc level or higher in a relevant scientific subject area or proven experience in a relevant regulatory role
  • Minimum of 5 years' experience in a senior regulatory management role 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

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