Regulatory Affairs Specialist Location: Hybrid – Worksop (with occasional travel to Vernacare sites) Reports to: Regulatory Affairs Manager Join Vernacare and help shape the future of sustainable healthcare At Vernacare, we’re committed to protecting people and the planet through innovative, sustainable healthcare solutions. As a Regulatory Affairs Specialist within our QARAC (Quality, Assurance, Regulatory Affairs & Compliance) team, you’ll play a critical role in ensuring our products meet the highest regulatory standards while supporting innovation and growth across our portfolio. The Opportunity: This is a key position within the QARAC team, responsible for supporting regulatory compliance across the full product lifecycle—from development through to post-market activities. You’ll act as a subject matter expert on regulatory requirements, working closely with colleagues across R&D, Quality, Manufacturing and Commercial teams to ensure that products are compliant, competitive, and aligned to evolving regulatory frameworks. This is a hybrid role, with flexibility built in, alongside occasional travel to Vernacare sites across the UK to support collaboration, audits and project activity. What You’ll Be Doing: Regulatory Compliance & Strategy Support the development and implementation of regulatory strategies for new and existing products Ensure compliance with applicable regulations including UKCA, CE marking (EU MDR) and other international requirements where applicable Interpret regulatory requirements and provide clear, pragmatic guidance to the business Technical Documentation & Submissions Prepare, review and maintain technical files and regulatory documentation in line with regulatory expectations Support product registrations, submissions and regulatory approvals across relevant markets Ensure documentation is inspection-ready at all times Product Lifecycle Management Provide regulatory input into new product development (NPD) and design change activities Support change control processes and assess regulatory impact of product or process changes Contribute to post-market surveillance activities, including vigilance and reporting where required Stakeholder & Authority Interaction Act as a key contact for notified bodies, regulatory authorities and external partners Support and participate in regulatory audits and inspections Build strong relationships internally to ensure regulatory considerations are embedded early Regulatory Intelligence & Continuous Improvement Monitor changes in regulations, standards and guidance (e.g., MDR updates, UK regulations) Assess impact to Vernacare’s products and processes, providing recommendations and action plans Contribute to the continuous improvement of regulatory systems, processes and ways of working within QARAC What We’re Looking For: We’re looking for someone who combines technical regulatory expertise with a collaborative, solutions-focused mindset. Experience & Knowledge Proven experience in a Regulatory Affairs role within medical devices, healthcare or another highly regulated industry Strong working knowledge of EU MDR, UKCA and CE marking requirements Understanding of quality management systems (e.g., ISO 13485) and how regulatory and quality overlap Experience supporting technical documentation, submissions and audits Skills & Attributes Excellent attention to detail with strong documentation and technical writing skills Ability to interpret complex regulations and translate them into practical business guidance Confident stakeholder management skills, with the ability to influence across functions Strong organisational skills and ability to manage multiple priorities Proactive, adaptable, and comfortable working in a changing regulatory environment Why Join Vernacare? Be part of a purpose-led business focused on sustainable healthcare solutions Work within a collaborative and supportive QARAC team Enjoy flexible hybrid working Gain exposure across multiple UK sites and functions Be part of a company that values innovation and continuous improvement We offer a competitive benefits package designed to support your wellbeing and reward your contributions: Life Insurance – 4x salary 25 Days Annual Leave Bank Holidays Enhanced Sick Pay Scheme EV & Cycle to Work Salary Sacrifice Schemes Employee Assistance Programme – includes 24/7 GP access Mental Health First Aiders Refer a Friend Scheme – up to £1,000 Company Pension Scheme Quarterly Impact Awards – up to £2,500 Manager Recognition Awards Be the driving force behind Vernacare’s growth and work with a company committed to sustainability and innovation. Interested? If you’re looking for a role where your expertise will make a real impact, we’d love to hear from you. Apply now and be part of Vernacare’s mission to create a more sustainable healthcare future.