Senior Director Regulatory Affairs
1 month ago
Oxford Nanopore Technologies is a leading company in the field of nanopore-based DNA/RNA sequencing technology. Our goal is to enable the analysis of any living thing, by anyone, anywhere. We offer real-time nanopore-based DNA/RNA sequencing technology: accessible, easy to use and fully scalable for any requirement.
Job SummaryWe are seeking a highly experienced Senior Director Regulatory Affairs to join our team. The successful candidate will be responsible for ensuring the firm fully complies with its regulatory obligations, to oversee the operation and functions of the Regulatory Affairs team and to ensure compliance with its Quality Management System (QMS).
Key Responsibilities:- Manage the Regulatory, Risk Management, PMS and Clinical Affairs functions.
- Establish strong working relationships across the business to facilitate best practices in the risk management, product development, testing, manufacture and post market surveillance of products.
- Lead all Health Authority interactions and communications (pre-submissions, submissions, recalls etc.).
- Regularly monitor data outputs from functions which have regulatory relevance e.g. complaints and customer feedback.
- 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.
- Ensure training on regulatory processes is developed and maintained and assigned appropriately.
- Establish and maintain an effective Post Market Surveillance system to meet regulatory requirements.
- Provide regulatory support to internal and external audits and inspections.
- Support and progress the compilation of regulatory submissions.
- Provide regulatory support in the correct application of technical standards to meet regulatory requirements and industry best practices.
- Qualification to BSc level or higher in 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.
- Direct experience of assembling and submitting FDA 510k and CE Tech File (to IVDR) reviews.
- Detailed understanding of risk management, process validation, clinical validation, electrotechnical instrumentation compliance and IVD V&V standards.
- Experience of working in an IVD environment along with practical experience in working to applicable standards (e.g. ISO 13485, ISO 14971, ISO 9001).
- 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: IEC 62304, IEC 62366, GLP, EMC.
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