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. #J-18808-Ljbffr
Contact Details:
Vernacare International Ltd Recruitment Team
