Medical Device Quality Specialist Consultant (Medical Devices)

Location: Hybrid working in the United Kingdom, based at either the London Victoria or Melbourn office, with at least 2–3 days per week in the office or on a client site and up to 5 days per week on a client site depending on the assignment.

Company

hirify.global is a global consulting firm combining strategy, innovation, design, science, engineering, and technology expertise across industries including health and life sciences.

What you will do

• Advise clients on medical device quality systems and regulatory requirements across development and post-market stages.
• Author, review, and maintain Design History Files, risk management files, technical documentation, and change control records.
• Support supplier qualification, audits, gap assessments, CAPA, complaints investigations, vigilance, and post-market surveillance.
• Provide specialist support for Software as a Medical Device, including software development lifecycle oversight and compliance with IEC 62304 and IEC 82304.
• Support regulatory submissions, technical dossiers, technology transfer, process validation, equipment qualification, and technical knowledge transfer.
• Lead or contribute to cross-functional consulting project teams, managing quality deliverables and supporting stakeholder decision-making.

Requirements

• Degree in life sciences, pharmacy, engineering, or a related discipline.
• Typically 8+ years of experience in the medical device industry.
• Hands-on knowledge of quality systems and regulatory frameworks, including ISO 13485, QMSR, 21 CFR Part 4, FDA, UK MDR, and EU MDR.
• Experience with quality and technical documentation, risk management under ISO 14971, supplier quality, audits, CAPA, and document control.
• Understanding of human factors and usability engineering, with strong communication, organisation, and project management skills.
• Applicants must be British citizens or have been continuously resident in the UK for the past 5 years to meet security-clearance residency requirements where applicable.

Nice to have

• Prior management consulting experience.
• Knowledge of drug–device or biologic–device combination products, including CCIT and stability or compatibility studies.

Culture & Benefits

• Interdisciplinary work focused on complex challenges in health and life sciences.
• Private healthcare and health and lifestyle benefits.
• 25 days of annual leave plus a bonus half day on Christmas Eve, with the option to buy 5 additional days.
• Company pension scheme, annual performance-based bonus, and PA share ownership.
• Tax-efficient benefits and opportunities to participate in community and charity initiatives.

Hiring process

• Complete the online application.
• Successful applicants may need to complete background checks and meet Baseline Personnel Security Standard or higher UK security-clearance requirements.