Head of Regulatory Affairs THE COMPANY Our client, a world-leading biotech company, is at the forefront of liquid biopsy technology.
They have developed a patent-protected platform that captures rare circulating tumour cells (CTCs) from blood in a minimally invasive manner, pushing the boundaries of cancer diagnostics and personalised medicine.
Their groundbreaking system, the first FDA-cleared device of its kind, enables the collection and analysis of intact circulating cancer cells, offering new insights into metastatic disease.
The company 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.
In this key leadership role, you will act as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets.
You will provide strategic direction and operational oversight to the regulatory and quality teams, managing compliance with international medical device directives and regulations, including ISO13485 and ISO15189.
You will play an essential role in new product development (NPD) by defining regulatory strategies, guiding clinical and analytical validation studies, and liaising with regulatory authorities.
This position offers the opportunity to influence the global commercial rollout of a revolutionary cancer diagnostic technology.
ABOUT YOU The ideal candidate will possess: 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.
HOW TO APPLY If you are an experienced regulatory professional with a passion for innovation in cancer diagnostics, this is an exciting opportunity to make a significant impact.
If this sounds like the right opportunity for you, apply here or email ****** for more information.