Regulatory Affairs Director
3 weeks ago
Establishing a strong foundation for regulatory compliance is crucial for the success of Oxford Nanopore Technologies. As Senior Director Regulatory Affairs, you will be responsible for overseeing the operation and functions of the Regulatory Affairs team, ensuring that both OND and ONT meet their regulatory obligations with regards to product development, manufacture, and distribution.
Key Responsibilities:- Manage the Regulatory, Risk Management, PMS 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 of products
- Regularly monitor data outputs from functions which have regulatory relevance e.g. complaints and customer feedback
The ideal candidate will have a BSc degree 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 is required.
Salary Range:We are offering a competitive salary range of £80,000 - £110,000 per annum, depending on experience.
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