SVP Regulatory Affairs & Quality Assurance
- Hiring Organisation
- PrecisionLife
- Location
- Oxford, England, United Kingdom
Responsibilities — Data Governance & Cross-Functional Partner with the DPO and ISO 27001 & ISO 27701 Committee Management Team on Data Security and GDPR compliance for genomic and special-category data, including DPIAs, international transfers and data subject rights. Embed quality and regulatory thinking into Product … initiated for products on a path to 510(k) / De Novo. Support completion of consumer-scale privacy and data flows validated under GDPR, ISO 27701 and applicable US state genomic privacy requirements. PMS, vigilance, complaint handling and CAPA systems operational at consumer scale with measurable KPIs. RA / ...