Quality/Regulatory Manager - SaMD
slough, south east england, united kingdom
Hobson Prior
that to be considered for this role you must have the right to work in this location. Responsibilities: Oversee and manage a quality management system (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 inspection. Develop … marking, MHRA Class 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 More ❯
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