Working within our multidisciplinary teams on major medical and drug device development projects, you will be responsible for advising our clients and internal teams on Human Factors regulatory requirements and working in collaboration with our Human Factors Specialists to develop human factors/usability engineering files, Design History/Technical Files (DHF) and use-related risk documentation, ensuring best practice and acting as primary author for key documents.
You will come from a quality, risk management and/or regulatory background and have applied knowledge and understanding of human factors requirements for medical devices, diagnostic devices and combination products. Positive and professional, you will be experienced in regulatory leadership and risk management best practice and confident in presenting progress to clients. This role will suit an ambitious individual who is looking to make an immediate impact in our team and for further training and career development.
- 2 or above in an Engineering or Science degree
- A deep understanding of current regulations in medical devices and drug/device combinations
- Proven experience working with human factors specialists to guide their activities and translate their findings in alignment with FDA human factors guidelines, IEC62366 and the latest MDR requirements
- Managed, prepared and authored Use Risk Management Files including; Plans, Hazard Assessments, uFMEA and Risk Reporting
- Managed, prepared and authored human factors/usability engineering files for submission to regulatory authorities in the EU and US
- Worked closely with technical development teams of medical devices from requirements capture to validation, working within an ISO 13485 QMS
- Excellent communication skills with clients and within teams at all levels
- Demonstrated self-motivation and organisation, collaborating with others, and leading project teams with limited guidance
- Experience across a broad range of medical product including combination devices, diagnostic, therapeutic and surgical medical devices would be a distinct advantage