We are seeking a highly skilled consultant with experience in medical device development to join our Life Sciences consulting team. This role focuses on the development of medical devices, including 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 while driving innovation in MedTech and pharmaceutical product development.
Key Responsibilities:
Technical Leadership
- Act as a systems engineering leader, bringing together multi-disciplinary teams - design, mechanical, electrical, software, quality and regulatory - to develop complex medical and drug delivery devices.
- Define system architecture, ensuring alignment with safety, usability, and regulatory requirements (ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR 4/ 820).
- Oversee technical project management, ensuring clear requirements, risk management, and seamless integration of cross-functional expertise.
- Lead end-to-end product development, from user needs analysis and design to development, verification, validation, and regulatory approval.
Regulatory & Quality Compliance for Medical/ Drug Delivery Devices
- Provide expertise on global regulatory requirements for medical/ drug delivery devices, ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
- Lead risk management activities (ISO 14971), ensuring safety and efficacy through robust design and process controls.
- Guide processes for hardware, software, and AI-driven medical devices, including compliance with IEC 62304 (medical software lifecycle processes) and IEC 62366 (usability engineering for medical devices).
- Develop and optimise Quality Management Systems (QMS) to streamline compliance and lifecycle management.
Stakeholder & Client Engagement
- Work closely with clients, R&D teams, business stakeholders, and regulatory 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.