Regulatory Affairs Officer
Location: 20 Cambridge Science Hub, Bar Hill, CB23 8SQ
Salary: Competitive, DOE + Excellent Benefits!
Contract: Full time, Permanent, Monday - Friday, 8am - 5pm
Benefits: 21 days holiday + 8 bank holidays and an additional day off for your birthday, comprehensive pension scheme, and healthcare benefits!
This is an exciting and challenging opportunity to join a leading biotech company with branches in Cambridge (UK), Houston (US) and Leiden (NL), providing products and services globally.
We are looking for a Regulatory Affairs Officer to join our dynamic team in Bar Hill, Cambridge. This is a fantastic opportunity for a regulatory professional with strong experience in Medical Devices regulatory frameworks.
In this varied role, you'll assist the team with guiding products from inception and development through to market launch and beyond. The successful candidate will be the Person Responsible for Regulatory Compliance (PRRC) for Abbexa.
Role & Responsibilities
1. Develop, implement, and maintain ISO 13485-compliant Quality Management System (QMS) to meet IVDR requirements for UK/EU product development and manufacturing
2. Create, manage, and update regulatory and quality documentation, including procedures, guidelines, and cross-functional work instructions, providing subject-matter expertise to support regulatory str...