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 MedTech and pharmaceutical product developments.

Key Responsibilities:

Regulatory & Quality Compliance for Medical Devices and Combination Products

• 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

Stakeholder & Client Engagement

• 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.