Regulatory Affairs Director
2 weeks ago
Singular: Building Brilliant Biotechs is at the forefront of liquid biopsy technology, developing a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner.
The Company
Our client operates a UK-based Clinical Laboratory in Guildford and is expanding its services globally, integrating advanced molecular profiling techniques such as digital PCR and NGS.
The Role
We are seeking an experienced Head of Regulatory Affairs to join our client's team in Guildford, providing strategic direction and operational oversight to the regulatory and quality teams.
Key Responsibilities
- Ensure the organisation meets all relevant regulatory standards across global markets, adhering to international medical device directives and regulations, including ISO13485 and ISO15189.
- Define regulatory strategies, guide clinical and analytical validation studies, and liaise with regulatory authorities.
- Manage compliance with global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards.
- Play an essential role in new product development (NPD) by influencing the global commercial rollout of a revolutionary cancer diagnostic technology.
Requirements
- Extensive 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.
About You
The ideal candidate will possess a strong background in regulatory affairs, with a passion for innovation in cancer diagnostics. If this sounds like the right opportunity for you, we encourage you to apply.
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