Regulatory Affairs Director
13 hours ago
We are seeking an experienced Compliance Expert to lead our regulatory and quality teams in Guildford.
This key leadership role will act as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR, ensuring the organisation meets all relevant regulatory standards across global markets.
The successful candidate will provide strategic direction and operational oversight to the regulatory and quality teams, managing compliance with international medical device directives and regulations, including ISO 13485 and ISO 15189.
Main Responsibilities:
- Act as the Person Responsible for Regulatory Compliance (PRRC) for MDR/IVDR
- Provide strategic direction and operational oversight to the regulatory and quality teams
- Manage compliance with international medical device directives and regulations
Key Requirements:
- In-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards
- Experience in IVD medical device product development, adhering to standards such as ISO 14971
Salary: £90,000 - £110,000 per annum. We offer a competitive compensation package commensurate with experience.
About Our Company:
Singular: Building Brilliant Biotechs is a world-leading biotech company at the forefront of liquid biopsy technology.
Our revolutionary cancer diagnostic technology has enabled the collection and analysis of intact circulating cancer cells, offering new insights into metastatic disease.
We operate a UK-based Clinical Laboratory in Guildford and are expanding our services globally, integrating advanced molecular profiling techniques such as digital PCR and NGS.
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