Medical Device Quality Specialist Consultant (MedTech)

Location: Hybrid role based at the London Victoria or Melbourn (SG8) office, United Kingdom, with office or client-site attendance required at least 2–3 days per week and potentially up to 5 days per week on a client site.

Company

Global consulting organisation providing strategy, innovation, technology, engineering, and life sciences expertise to help clients develop and commercialise complex products.

What you will do

• Advise clients on medical device, SaMD, and combination product quality and regulatory requirements.
• Develop and maintain quality systems, Design History Files, risk management files, technical documentation, and change control records.
• Support supplier qualification, audits, gap assessments, regulatory submissions, technical dossiers, and responses to authorities and notified bodies.
• Lead or support technology transfer, process validation, equipment qualification, scale-up, and technical knowledge transfer.
• Lead ISO 14971 risk management activities and support post-market surveillance, vigilance, complaints investigations, CAPA, and documentation.
• Manage quality deliverables and actions within cross-functional client project teams.

Requirements

• Significant experience, typically 8+ years, in the medical device industry.
• Degree in life sciences, pharmacy, engineering, or a related discipline.
• 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.
• Experience with human factors or usability engineering and strong communication, organisational, and project management skills.
• UK residency eligibility may be required for security clearance; some roles require British citizenship or at least five years of continuous UK residency.

Nice to have

• Prior management consultancy experience.
• Knowledge of drug–device or biologic–device combination products, CCIT, and stability or compatibility studies.
• Experience with IEC 62304 and IEC 82304 for SaMD development.

Culture & Benefits

• Interdisciplinary work on complex life sciences and healthcare challenges.
• Inclusive workplace focused on equality, diverse perspectives, and meaningful client work.
• Private healthcare and health and lifestyle benefits.
• 25 days of annual leave, plus a half day on Christmas Eve and the option to buy five additional days.
• Company pension scheme, performance-based bonus, share ownership, and tax-efficient benefits.
• Opportunities to participate in community and charity initiatives.

Hiring process

• Submit an online application.
• Complete required background checks and, where applicable, UK security clearance procedures.