Job Description Biocomposites, Ltd. is an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue. Based in Keele in Staffordshire, UK, it has global operations across Europe, USA, Canada, Argentina, China and India, and helps more than 1 million patients worldwide every year We are distinct in that our team of specialists is singularly focused on the development of innovative calcium compounds and all research, manufacture and distribution takes place at our headquarters in Keele, England. In 2022, Her Majesty the Queen honoured us with two Queen’s Awards for Enterprise in Innovation and International Trade in recognition of the impact of STIMULAN in infection cases and our outstanding continuous growth in overseas sales of more than 200% over six years. Biocomposites products are now used in over 120,000 procedures every year and sold in more than 40 countries around the world. BACKGROUND: Biocomposites continues to experience dramatic growth, realising our mission to increase the number of patients we can help, by extending our market coverage in new specialities and new geographies. The Risk Management Specialist is responsible for the involvement in creating and maintaining Risk Management Files for all products throughout its life cycle, including FMEA scoring systems, risk management plans, and various pre and post market analysis reports. RESPONSIBILITIES: Assist in the creation and maintenance of Risk Management files for medical devices, including: Failure mode effects analysis scoring system, Risk management plans, Preliminary hazard analysis reports, Risk hazard analysis reports, Register of risks (DFMEA), Risk-benefit analysis, Risk-traceability analysis, Anomalies review reports and Risk management reports. Identify risks using applicable risk assessment tools, and best practice tools and techniques. Periodically review the risks and risk treatment strategies in order to update, eliminate or add risks and to meet reporting requirements. Participate in risk reviews for proposed design changes. Create risk control requirements as inputs to product design. Ensure that the effective operation of risk management can be evidenced and provide confidence to internal and external stakeholders Ensuring a culture of risk-based decision-making is maintained within the organisation. Other duties in support of the company’s quality policy and objectives. REQUIRED EXPERIENCE: Level 6 within a science regulated industry or relevant experience Minimum 5 years risk management experience within Pharmaceutica/Medical Devices Knowledge of Quality Management Systems ISO14971 Excellent communication skills People management skills Ability to take initiative within controlled working environment Ability to meet deadlines Attention to detail Level 5 in Leadership Management Member of a chartered institute Ability to work in a diverse, dynamic and fast-paced environment Excellent team player, with strong interpersonal and communication skills What do we offer? Competitive salary and benefits With us, you will receive a competitive salary package and benefits. We grow talent. At Biocomposites we create opportunities to thrive and grow. One Biocomposites – team spirit & engagement. Our culture is important and we strive to create engaged and inclusive global teams that encourage colleagues to share their diverse perspectives and opinions. Who do we look for? People who are passionate about what we do. People who are open minded to evolving the way we work. People who can work together to transform outcomes and change lives. Benefits: Company events Company pension Employee discount Free or subsidised travel Free parking