PPE, equipment and stock levels within the vehicle. Report any damage or shortages to the office to enable replacements to be arranged as necessary. Be aware of the QualityManagementSystem which includes policies in place to support the business and its aims including but not limited to Health & Safety, Environmental, Data Protection, Anti-bribery & equality. Further information can be More ❯
SaaS agreements. Operational & Structural Projects: Manage carve-out operations, including partial asset transfers and establishing subsidiaries in foreign jurisdictions. Develop and implement business continuity plans and QualityManagement Systems (QMS). Risk & Incident Management: Devise and monitor risk mitigation strategies. Track and address quality-related incidents to maintain high standards. Influence & Lobbying: Define and execute strategies for industry influence and More ❯
maintain excellence. Please note that to be considered for this role you must have the right to work in this location. Responsibilities: Oversee and manage a qualitymanagementsystem (QMS) that complies with ISO 13485 standards. Handle document control, change management, corrective actions, training records, audits, and supplier oversight. Lead internal and external audits, ensuring systems are always ready for … I-II, FDA registration, and 510(k) processes. Maintain technical files and coordinate cross-functional inputs to meet regulatory deadlines. Key Skills and Requirements: Experience managing ISO 13485-compliant QMS and leading audits. Familiarity with Software as a Medical Device (SaMD) is essential. Strong knowledge of UKCA, MHRA, FDA regulations, and cybersecurity standards such as DTAC, DSPT, DCB, and Cyber More ❯
