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. * Experience in a senior or lead role within Regulatory Affairs The successful candidate will be the Person Responsible for Regulatory Compliance (PRRC) for Abbexa. * Create, manage, and update regulatory and quality documentation, including procedures, guidelines, and cross-functional work instructions, providing subject-matter expertise to support regulatory strategy * Act as the Person Responsible for Regulatory Compliance (PRRC), fulfilling all obligations defined under IVDR Article 15 (e.g., oversight of technical documentation, conformity assessment, PMS, vigilance) * Monitor evolving regulatory requirements, evaluate their business impact, and implement ...
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