Medical Device Quality Specialist Consultant

Overview

In this role you help clients design, develop and manage compliant medical devices and combination products across their lifecycle. You work within cross‑functional teams to embed robust quality systems and navigate regulatory requirements, from development to post‑market. You’ll advise on design controls, risk management and regulatory submissions, while leading technology transfer, validation and post‑market activities. This position offers impact in improving patient outcomes through regulatory excellence and lifecycle quality management.

Pay / Benefits

• private healthcare
• 25 days annual leave
• generous pension
• community/charity initiatives
• annual performance-based bonus
• PA share ownership

Responsibilities

• Support Quality Management Systems compliant with ISO 13485 and QMSR
• Create and maintain Design History Files, risk management files, technical documentation, and change controls with traceability
• Lead supplier qualification, audits and gap assessments ensuring global regulatory alignment
• Advise on medical device quality and regulatory requirements for US/EU market access (design, development, risk, documentation)
• Provide specialised SaMD support, oversee SDLC and ensure IEC 62304 and IEC 82304 compliance
• Understand regulatory considerations for combination products (drug–device, biologic–device) and CCIT and stability studies
• Interpret and apply evolving global combination product regulations; support regulatory submissions and responses to authorities
• Lead or support technology transfer across development, scale‑up and manufacturing, with process validation and equipment qualification
• Drive risk management per ISO 14971, post‑market surveillance, CAPA and complaint investigations
• Work in cross‑functional project teams to manage quality deliverables and decision‑making

Key requirements

• 8+ years in medical device industry
• Degree in life sciences, pharmacy, engineering or related discipline
• Strong knowledge of ISO 13485, 21 CFR Part 4, FDA, UK MDR, EU MDR
• Experience authoring quality and technical documentation in regulated environments
• Risk management expertise (ISO 14971) and usability engineering knowledge
• Experience with supplier quality, audits, CAPA and document control
• Excellent communication, organizational and project management skills with diverse stakeholders
• Experience with regulatory submissions and technical dossiers

• Excellent communication
• Organisational skills
• Project management
• ISO 13485
• 21 CFR Part 4, FDA
• EU MDR, UK MDR

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