SVP Regulatory Affairs & Quality Assurance
- Hiring Organisation
- PrecisionLife
- Location
- Oxford, England, United Kingdom
establish and report QMS performance metrics for the executive team and Board. Own document control, training records, CAPA, nonconformance, change control, internal audit and supplier audit programmes for product related certifications and regulatory bodies. Direct selection process, audit and monitoring of external suppliers and manufacturing … related discipline. PhD or RAC (Regulatory Affairs Certification) preferred but not essential where equivalent senior operational experience is demonstrated. ISO 13485 accreditation and audit experience Working knowledge of ISO 14971, IEC 62304, IEC 82304, ISO 15189 and IEC 81001-5-1. Working knowledge ...