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. The Regulatory Affairs Projects Manager provides leadership and oversight of regulatory projects and staff including new or renewed product registrations and claims in accordance with regulatory requirements. RESPONSIBILITIES: Manage and support regulatory projects including: New product registrations New product claims Existing product renewals Ensure relevant information is submitted to organizations/regulatory bodies for product registration. Such information may be redacted to retain confidentiality and protect proprietary knowledge. Ensure Technical Documentation is available and maintained. Assess the impact of design changes for regulatory compliance and the implications for maintaining regulatory compliance. Authority to release product on concession if regulatory requirements are met. Provide leadership, management and oversight of regulatory staff. Promote awareness to staff on meeting customer, quality and regulatory requirements. Maintain a regulatory management role which is independent of the purchasing, manufacturing and testing functions. Report the implications of regulatory changes to Management Review. REQUIRED EXPERIENCE: Bachelor’s Degree in a life science discipline or equivalent. Minimum 8 Years’ experience with Medical Devices (or pharmaceutical) manufacturer with quality or regulatory responsibilities (i.e. above ‘entry level’ positions). Proven regulatory experience of EU & US medical device regulations as a minimum. Hosted notified body/regulatory agency audits. Compilation of Technical Files/Documentation to MDD 93/42/EEC or MDR 2017/745. Experience of ISO 13485 QMS. Working knowledge of applicable medical device regulations and/or standards. Participation in biocompatibility evaluation, risk assessment, post market surveillance or clinical evaluation reports. Ability to assess conflicting demands and prioritise tasks in a fast paced and evolving environment. Make timely and effective decisions for the execution of project objectives. Takes accountability for the regulatory projects to meet business goals and objectives. Ability to review audit reports and action accordingly. Flexible approach to work. Right to work in the UK LOCATION & WORKING PATTERN Keele Science Park, Keele, Staffordshire, England, ST5 5NL 09:00-17:00 (or 08:00-16:00) on-site min 3 days per week expected with additional days according to business needs (e.g. audits requiring on-site attendance, submission deadlines) 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