Product Risk Management Specialist

Role Overview

We are looking for an analytical and detail-oriented engineer or technical specialist who enjoys understanding how products can fail, identifying risks, and working with multidisciplinary teams to develop practical solutions. Whilst experience with medical device risk management is advantageous, we are equally interested in candidates who can demonstrate strong problem-solving skills, technical curiosity, systems thinking and the ability to work with complex information.

We recognise that excellent risk management professionals can come from a variety of technical backgrounds. Full training and mentoring will be provided on Rayner's Risk Management processes, tools and the practical application of ISO 14971.

Please note that this role is based on-site at Global HQ in Worthing, West Sussex.

What You'll Be Doing

• Lead the development and maintenance of Product Risk Management documentation for new and existing medical devices, working within established company procedures and international standards. Training will be provided on the specific application of ISO 14971 where required.
• Facilitate cross-functional risk reviews, ensuring appropriate input is obtained from engineering, manufacturing, quality, clinical and regulatory stakeholders.
• Capture and document risk assessments relating to product design, manufacturing processes and product use, ensuring information is accurate, traceable and maintained in accordance with company procedures.
• As part of the R&D Product Risk Management team, represent the R&D Product Risk Management function on multi-disciplinary teams working on research, NPD, process improvement, regulatory and clinical projects, providing information, guidance and support on all product risk management aspects.
• Work closely with R&D, Vigilance, Quality, Validation, Process Engineering, Production and external suppliers (factored products only) to effectively and efficiently maintain Product Risk Management files in accordance with company SOPs and international standards.
• Ensure that Risk Control Measures (e.g. Manufacturing SOPs, Design Verification and Biological Evaluation activities) are appropriate and up to date as company processes and practices continuously improve.
• Maintain a high standard of professional and technical knowledge by attending educational training/workshops, reviewing professional publications, establishing networks, and participating in professional societies.