Medical Device Regulatory and Quality Consultant

Medical Device Regulatory and Quality Consultant

We are seeking a highly skilled consultant with experience in medical device and/or combination product Quality and Regulatory processes to join our Healthcare & Life Sciences (HLS) consulting team. This role focuses on advising clients on the regulatory, Quality and compliance aspects of medical devices, through a strong understanding of regulatory and quality requirements for medical devices, software as a medical device (SaMD), and/or combination products.

The ideal candidate will have experience leading complex technical projects, integrating multidisciplinary expertise, and ensuring regulatory and quality compliance in innovative Med Tech and pharmaceutical product developments.

• Provide expertise on global regulatory requirements for medical devices and combination products ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
• Guide processes for hardware, software, and AI-driven medical device development to ensure compliance with applicable regulatory standards and guidance, including ISO 13485, ISO 14971, IEC 62304, and related standards and guidance for AI-driven medical technologies.
• Advise cross‑functional teams of designers, mechanical, electrical, software and usability engineers on requirements and best practices for regulatory and quality compliance.
• Ensure requirements traceability from user needs through design, development, verification, and validation.
• Lead risk management activities in accordance with ISO 14971, ensuring safety and efficacy through robust design and process controls.
• Develop and optimise clients’ Quality Management Systems (QMS) to streamline compliance and lifecycle management.

• Work closely with clients’ R&D teams, business stakeholders, and notified bodies to align project goals with industry requirements.
• Facilitate cross‑functional collaboration, ensuring smooth integration between engineering, quality, and regulatory disciplines.
• Translate complex technical and regulatory requirements into actionable development strategies for medical technologies.

Flexible working – we are guided by our client work and needs; however, you have autonomy to manage your time and diary to suit your work/life balance.

• A technical background in Engineering (systems, biomedical, mechanical, electrical, software, or related field) or Applied Science (physics, chemistry, biology, materials science, etc.).
• Demonstrated prior direct experience in the design, development, or testing of medical devices and/or combination products.
• At least five years’ experience in Med Tech, pharmaceuticals, or life sciences, with a strong track record in regulated product development.
• Deep expertise in regulatory frameworks (FDA, EMA, MDR/IVDR, ISO 13485, IEC 62304, ISO 14971, GAMP, 21 CFR 4/820).
• Proven ability to work cross‑functionally with engineering, quality, and regulatory teams, contributing practical insights from previous technical roles.
• Strong problem‑solving skills, troubleshooting expertise and the ability to drive technical decision‑making in a highly regulated environment ensuring alignment with business and regulatory needs.
• Ability to manage multiple concurrent projects.

• Health and lifestyle perks accompanying private healthcare for you and your family.
• 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days.
• Generous company pension scheme.
• Opportunity to get involved with community and charity‑based initiatives.
• Annual performance‑based bonus.
• PA share ownership.
• Tax‑efficient benefits (cycle to work, give as…