Biotech Regulatory Head
24 hours ago
We are seeking an experienced Regulatory Affairs Director to join our team 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:
- Proven experience in regulatory affairs and compliance
- In-depth knowledge of global medical device directives, including FDA regulations, MEDDEV guidelines, and ISO standards
Salary: £80,000 - £100,000 per annum. We offer a competitive salary and benefits package commensurate with experience.
About Our Company:
Singular: Building Brilliant Biotechs is a pioneering biotech company at the forefront of liquid biopsy technology.
Our revolutionary cancer diagnostic technology has transformed the field of cancer diagnostics and personalised medicine.
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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