SVP Regulatory Affairs & Quality Assurance
- Hiring Organisation
- PrecisionLife
- Location
- Oxford, England, United Kingdom
2016. Participate in the Management Review process; 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 … enhance the company’s existing ISO 27001 (Information Security Management) and ISO 27701 (Privacy Information Management) certification related activities, including risk assessments, SoA, document control implementation. Key Responsibilities — Regulatory Define and execute global regulatory strategy across EU IVDR, UK (UKCA/MHRA), US (FDA 510(k), De Novo ...