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Quality Assurance & Regulatory Affairs (QARA) Manager Medical Devices Location: Hertford, Hertfordshire Contract Type: Contract About Us We are an ambitious and rapidly growing medical device company developing innovative products that improve patient outcomes and support healthcare professionals worldwide. As we continue to expand our product portfolio and international market presence, we are seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead our Quality and Regulatory function and play a critical role in bringing new medical devices to market. This is an exciting opportunity for someone who thrives in a hands-on SME environment and enjoys building systems, processes, and documentation from the ground up while working closely with engineering, manufacturing, and leadership teams. The Role Reporting directly to senior leadership, you will take ownership of Quality Assurance and Regulatory Affairs activities across a growing portfolio of medical devices. You will be responsible for developing and maintaining technical documentation, supporting product development activities, ensuring regulatory compliance, and driving quality throughout the entire product lifecycle. We are specifically looking for someone who has experience managing multiple medical device products and projects simultaneously, rather than supporting a single product line. This role requires a highly collaborative individual who can work effectively with R&D, engineering, manufacturing, suppliers, and external regulatory bodies while helping shape the future quality and regulatory strategy of the business. Key Responsibilities Regulatory Affairs • Lead the creation, maintenance, and submission of EU Technical Documentation and Technical Files from the ground up., • Support regulatory strategy for new and existing medical devices., • Prepare and maintain documentation in accordance with MDR (EU 2017/745)., • Coordinate regulatory submissions and product registrations in European and international markets., • Interface with Notified Bodies, Competent Authorities, and external regulatory consultants., • Review product changes and assess regulatory impact., • Maintain regulatory compliance throughout the product lifecycle., • Support future market expansion activities including UK, EU, US, and other international regions. Quality Assurance • Maintain and continuously improve the Quality Management System in accordance with ISO 13485., • Ensure quality requirements are integrated throughout product design, development, manufacturing, and post-market activities., • Support supplier qualification and supplier quality activities., • Lead internal audits and support external audits., • Ensure effective document control systems are maintained., • Provide quality and regulatory guidance to cross-functional teams., • Support implementation of scalable quality processes suitable for a growing business. New Product Development (NPD) • Act as the Quality and Regulatory representative within New Product Development projects., • Participate in design reviews throughout the development lifecycle., • Ensure Design Control requirements are effectively implemented and maintained., • Review design documentation including:, • Design Inputs, • Design Outputs, • Verification & Validation documentation, • Risk Management Files, • Clinical Evaluation documentation, • Usability Engineering documentation, • Support design transfer activities from development into manufacturing., • Work closely with engineering and production teams to ensure products are designed for manufacturability and regulatory compliance. Technical Documentation • Author and review:, • Technical Files, • Design Dossiers, • Risk Management Files, • Clinical Evaluation support documentation, • Regulatory submissions, • Product specifications, • Manufacturing documentation, • Quality procedures and work instructions, • Establish documentation structures and processes suitable for a growing product portfolio. About You You will be a proactive and technically strong QARA professional who enjoys operating in a fast-paced, entrepreneurial environment. You will be comfortable rolling up your sleeves and taking ownership while also contributing strategically to the company's future growth. Essential Experience • Degree in Engineering, Life Sciences, Medical Devices, Quality, Regulatory Affairs, or a related discipline., • Significant experience in Quality Assurance and Regulatory Affairs within the medical device industry., • Proven experience creating EU MDR Technical Documentation and Technical Files from scratch., • Strong knowledge of:, • EU MDR 2017/745, • ISO 13485, • ISO 14971, • Design Control requirements, • Product development lifecycles, • Experience supporting New Product Development and design transfer projects., • Experience participating in and leading design reviews., • Strong technical documentation writing skills., • Experience managing multiple products and regulatory projects simultaneously., • Experience working within an SME, start-up, or rapidly growing medical device company., • Excellent stakeholder management and communication skills. Highly Desirable • Experience with Class II or Class III medical devices., • Experience dealing directly with Notified Bodies., • Experience supporting international registrations., • Knowledge of FDA requirements and US market submissions., • Experience implementing or improving quality systems within a growing organisation., • Experience scaling regulatory and quality processes to support portfolio growth. Why Join Us? • Opportunity to shape the Quality and Regulatory function of a growing medical device business., • High visibility and direct interaction with senior leadership., • Influence future product development programmes., • Work across a diverse and expanding device portfolio., • Genuine opportunity for career progression as the company continues to grow., • Collaborative and innovative working environment where your expertise will make a real impact. If you are an experienced QARA professional looking for an opportunity to build, influence, and drive quality and regulatory excellence within a growing medical device company, we would love to hear from you.

Quality Engineer – NPD & Manufacturing Location: Hertford, Hertfordshire, UK Contract: Initial 6–12 Month Contract Hours: 40 Hours Per Week Sector: Medical Devices Quality Engineer – New Product Development & Manufacturing An exciting opportunity has arisen for an experienced Quality Engineer to join a rapidly growing medical device company based in Hertford. This is not a traditional Quality Systems or CAPA-focused role. Instead, we are seeking an engineering-led Quality professional who understands the complete product lifecycle, from concept and design through to manufacturing, testing, validation, and production release. Working closely with R&D, Manufacturing Engineering, Operations, and Regulatory Affairs teams, you will play a key role in bringing innovative medical devices from development into successful commercial manufacture. The role requires a strong understanding of design transfer, manufacturing processes, product testing, inspection methodologies, validation activities, and production quality assurance. The successful candidate will be equally comfortable reviewing engineering drawings and specifications, developing manufacturing documentation, validating production processes, and supporting new product introductions within a regulated medical device environment. Key Responsibilities New Product Development & Design Transfer • Support New Product Development (NPD) projects from concept through to commercial manufacture., • Work closely with Design, R&D, and Manufacturing Engineering teams throughout the product development lifecycle., • Participate in design reviews and provide input regarding manufacturability, testability, reliability, and product quality., • Support Design Transfer activities, ensuring products are successfully transitioned from development into production., • Review engineering drawings, specifications, BOMs, manufacturing instructions, and product requirements., • Ensure manufacturing and quality requirements are incorporated into product designs from an early stage., • Assist in developing production processes capable of consistently delivering compliant products at scale. Manufacturing Engineering & Production Support • Support manufacturing readiness activities for new product launches., • Develop and implement inspection methods, quality plans, test protocols, and manufacturing procedures., • Create manufacturing and quality documentation from scratch where required., • Work with production teams to optimise assembly and manufacturing processes., • Support Design for Manufacture (DFM) and Design for Assembly (DFA) initiatives., • Drive continuous improvement activities focused on process capability, product quality, and manufacturing efficiency., • Assist with supplier selection and component evaluation activities. Testing, Inspection & Product Verification • Develop and execute product testing strategies for new and existing products., • Establish incoming, in-process, and final inspection methodologies., • Perform and oversee product inspections against engineering specifications and acceptance criteria., • Support verification and validation testing activities., • Analyse test data and provide recommendations for product or process improvements., • Ensure robust traceability and documentation throughout manufacturing operations., • Review and approve production records and manufacturing documentation as part of batch release activities. Validation & Process Development • Lead or support process validation activities including IQ, OQ, and PQ protocols., • Develop validation documentation, protocols, reports, and acceptance criteria., • Support equipment qualification and manufacturing process development., • Participate in risk assessments, PFMEA activities, and process capability studies., • Ensure manufacturing processes are capable, repeatable, and suitable for production scale-up. Cross-Functional Collaboration • Act as the quality and manufacturing interface between Engineering, Operations, Regulatory Affairs, and Supply Chain teams., • Support technical investigations relating to product performance and manufacturing processes., • Collaborate with Regulatory Affairs to ensure product and manufacturing compliance requirements are met., • Contribute to technical decision-making throughout product development and manufacturing phases. Required Experience • Previous experience as a Quality Engineer, NPI Engineer, Manufacturing Engineer, Product Quality Engineer, or similar role within the medical device industry., • Strong understanding of New Product Development (NPD) processes., • Experience supporting products through the full lifecycle from design and development through to manufacturing and commercial release., • Experience working with design transfer activities within regulated manufacturing environments., • Strong understanding of medical device assembly and manufacturing processes., • Experience developing manufacturing procedures, work instructions, inspection plans, and test methods., • Experience with incoming, in-process, and final inspection activities., • Hands-on experience with product testing, validation, and verification activities., • Experience supporting process validation activities including IQ, OQ, and PQ., • Ability to interpret engineering drawings, specifications, tolerances, and technical documentation., • Strong understanding of Design for Manufacture (DFM) and Design for Assembly (DFA) principles., • Experience working within ISO 13485 regulated environments. Personal Attributes • Engineering-focused mindset with strong technical curiosity., • Practical and hands-on approach to problem solving., • Strong attention to detail and commitment to product quality., • Excellent communication and stakeholder management skills., • Ability to work effectively across multidisciplinary teams., • Self-motivated with the ability to manage multiple projects and priorities., • Comfortable operating within a fast-paced and growing organisation. What's on Offer • Opportunity to join an innovative and growing medical device business., • Work on cutting-edge products that directly impact patient outcomes., • Significant involvement in product development, manufacturing scale-up, and new product launches., • Collaborative engineering-led culture., • Competitive contract rate., • High visibility role with direct impact on company growth and product success. If you have a strong engineering background within medical devices and enjoy working at the intersection of product development, manufacturing, testing, and quality, we would love to hear from you.

Hays EA is a trading division of Hays Specialist Recruitment Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. An exciting opportunity has arisen for an experienced Repairs Manager to lead the delivery of a comprehensive r

Our client are a UK market leader in Catering and Refrigeration maintenance and as part of their continued growth they are looking for a fully qualified Commercial Catering Engineer to work in the Herts region. They require experienced engineers with full qualifications in COMCAT's Level 1, 2, 3 and 5 minimum. Our client is renowned for looking after their staff out-competing their competition on salary, benefits, flexibility but probably most importantly the way they treat their engineers which is proven in their tenure, which has meant they look after their clients with pride, care and commitment - hence the success and growth. There are regular opportunities to do more than your guaranteed 40 hours each week, on average our engineers work a 50 hours per week (Monday to Friday), this includes door to door travel and paid lunch breaks. 1 in 12 call-out rota and Saturday servicing additional overtime on offer too. Company van, with fuel cards and have auto pay parking, toll charges and congestion charges - the van is also available for personal use. Each engineer manages their own customer sites within a workable area, we don’t believe in travelling for hours to get to a site, it’s not productive. Our customers want the same engineer to look after them, which means building lasting relationships with the customer and their teams. The role is works throughout Herts. You will need r...

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