Risk Management Specialist

Risk Management Specialist in Worthing

Worthing Full-Time No home office possible

We are recruiting for a Maternity Cover in our Research & Development department here at Rayner.

This role gives you the opportunity to work in a leading global medical device company, using the latest equipment and tools to research & develop innovative products helping restore sight to millions of people all over the world. You will contribute to the design, development, manufacturing and testing of implantable medical devices and pharmaceutical products, working in multidisciplinary project teams from across the company. We are looking for a dedicated and detail-driven Individual to join our high-performing team for a fixed-term to make valuable contributions to our portfolio expansion globally.

Estimated end date: 30th April 2027. Please note this role is hybrid, with 3 days per week expected on-site at our flagship HQ in Worthing.

What You\’ll Be Doing:

Represent the R&D 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
Deliver and report on work packages within the scope of established Design Control and Risk Management procedures
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.
Take inputs from different processes and teams to assess, record and complete Risk Matrices related to Design, Manufacturing and Use of Rayner Medical Devices.
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.

What Experience & Skills You Will Need:

Essential

Qualification in Engineering or relevant technical discipline
Working knowledge of general engineering principles
Competence in key Microsoft Office packages (including Outlook, Word, Excel, Teams, SharePoint)
Demonstrable experience of effectively processing large amounts of data and Information In a methodical manner within a highly structured environment
Proven ability to generate high quality Technical Documentation

Desirable

Working knowledge of ISO 13485 (Design Control section) and ISO 14971
Experience of Risk Management tools such as FMEA
3+ years working within R&D/Regulatory/Quality Assurance in a regulated industry