Regulatory Affairs Director
1 day ago
We are seeking a seasoned Regulatory Affairs Director to lead our team in Guildford. In this key role, you will be responsible for ensuring our organisation meets all relevant regulatory standards across global markets.
This position requires strategic leadership and operational oversight to manage compliance with international medical device directives and regulations, including ISO13485 and ISO15189.
You will play a critical role in new product development (NPD) by defining regulatory strategies, guiding clinical and analytical validation studies, and liaising with regulatory authorities.
About the Role:
- Lead a team of regulatory professionals to ensure compliance with global medical device regulations.
- Develop and implement regulatory strategies to support NPD and commercialisation.
- Liaise with regulatory authorities to ensure timely and compliant submissions.
About You:
- A minimum of 5 years' experience in IVD medical device product development, adhering to standards such as ISO14971.
- In-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards.
What We Offer:
- An estimated salary range of £80,000 - £110,000 per annum.
- The opportunity to work on cutting-edge cancer diagnostic technology.
- A dynamic and collaborative working environment.
Benefits:
A comprehensive benefits package, including health insurance, pension scheme, and annual leave.
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