Medical Device Quality Specialist Consultant

Overview

As a Medical Device Quality Specialist Consultant, you support development and lifecycle management of medical devices and combination products, navigating regulatory complexity, embedding robust quality systems, and ensuring product safety and compliance from development through post‑market. You join multi‑disciplinary teams to apply deep technical expertise and strong stakeholder engagement. You’ll work across global regulations and standards to enable market access and patient outcomes. This role offers meaningful impact in a leading, innovative consulting environment.

Pay / Benefits

• private healthcare
• 25 days annual leave + 0.5 day Christmas Eve
• generous pension
• annual performance bonus
• PA share ownership
• tax efficient benefits (cycle to work, give as you earn)

Responsibilities

• Quality assurance and compliance within QMS (ISO 13485, QMSR)
• Maintain and author Design History Files, risk management, technical documentation, and change controls across product life cycle
• Support supplier qualification, audits, and regulatory gap assessments
• Advise on medical device quality and regulatory requirements for product design and development
• Provide support for SaMD SDLC and IEC 62304/IEC 82304 compliance
• Knowledge of combination products and regulatory considerations (CCIT, stability studies) is advantageous
• Interpret evolving global combination product regulations and assist in regulatory submissions and responses
• Lead or support technology transfer, process validation, and equipment qualification across development to manufacturing
• Lead risk management activities per ISO 14971 and support post‑market surveillance and CAPA
• Manage cross‑functional project teams and deliver quality outputs
• Author and maintain quality and technical documentation in regulated environments

Key requirements

• 8+ years of experience 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 with quality systems and regulatory frameworks
• Experience with supplier quality, audits, CAPA and document control
• Understanding of risk management (ISO 14971) and human factors/usability engineering
• Excellent communication, organizational and project management skills
• Consulting experience is highly desirable

• Strong communication
• Cross‑functional collaboration
• Stakeholder engagement
• Quality management systems (ISO 13485)
• Regulatory strategy and submissions
• Design History File management

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