Regulatory Affairs Director
1 week ago
Oxford Nanopore Technologies is a leading developer of innovative DNA sequencing technologies. We are seeking a highly experienced Senior Director, Regulatory Affairs to join our team in Oxford, UK.
The successful candidate will be responsible for ensuring the firm's compliance with regulatory requirements in the territories in which our IVD instruments and assays are sold. This will involve overseeing the operation and functions of the Regulatory Affairs team and ensuring compliance with our Quality Management Systems (QMS).
The postholder will have a detailed understanding of risk management, process validation, clinical validation, electrotechnical instrumentation compliance, and IVD V&V standards. They will also have a strong working knowledge of regulatory requirements applicable to IVD devices.
The ideal candidate will have a minimum of 5 years' experience in a senior regulatory management role in the IVD industry, with management responsibility for a team of professionals. They will be able to establish strong working relationships across the business to facilitate best practices in risk management, product development, testing, manufacture, and post-market surveillance of products.
The Senior Director, Regulatory Affairs will be responsible for providing regulatory input into the development and maintenance of Quality Systems to ensure compliance with regulatory requirements. They will also ensure the business is updated with regulatory expectations and intelligence.
The successful candidate will have the authority to review and approve product regulatory processes, documents, and records. They will also be responsible for establishing and maintaining an effective Post Market Surveillance system to meet regulatory requirements.
We are looking for a highly experienced and skilled individual who can provide strategic leadership and direction to our Regulatory Affairs team. If you have a strong background in regulatory affairs and a passion for ensuring compliance with regulatory requirements, we would love to hear from you.
Key Responsibilities:
- Ensure compliance with regulatory requirements in the territories in which our IVD instruments and assays are sold
- Oversee the operation and functions of the Regulatory Affairs team
- Ensure compliance with our Quality Management Systems (QMS)
- Provide regulatory input into the development and maintenance of Quality Systems
- Establish and maintain an effective Post Market Surveillance system
- Review and approve product regulatory processes, documents, and records
Requirements:
- Minimum of 5 years' experience in a senior regulatory management role in the IVD industry
- Management responsibility for a team of professionals
- 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
- Qualification to BSc level or higher in a relevant scientific subject area
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