SVP Regulatory Affairs & Quality Assurance
- Hiring Organisation
- PrecisionLife
- Location
- Oxford, England, United Kingdom
/QA will be responsible for ensuring PrecisionLife’s Mechanostic products meet all IVD and software/AI/SaMD related regulatory and quality requirements for their approval, marketing and lawful commercialization. The role will lead the implementation of ISO13485 and management of the related Quality Management System, the regulatory strategy across EU (IVDR), UK (UKCA/MHRA) and US (FDA, CLIA, LDT, SaMD) markets, and the regulatory and quality interfaces with biopharma partners on companion diagnostic (CDx) programmes (in the future). The role will also support the company’s existing information security ...