Regulatory Affairs & Quality Assurance Director

Job description

**Oxford, UK | Reporting to VP of Operations | Global travel including Boston, USA** ***(Anticipated start date for this role: January 2027)*** **Job Overview** The **RAQA Director**, is responsible for the strategic development and execution of the Company's regulatory affairs and quality assurance programs. Refeyn's products are currently sold as research/laboratory instruments rather than medical devices or IVDs, so this role is accountable for general product compliance (e.g. product safety, EMC, labelling, export/customs classification) across the US, EU, NMPA and other major global markets, rather than medical device-specific registrations. The role is also accountable for the execution and administration of Refeyn's electronic Quality Management System (eQMS) and associated Quality Systems, and for monitoring whether future products or customer use-cases trigger medical device, IVD, or other regulated-product obligations. As Refeyn's customer base increasingly moves from academic research into bioprocessing and industrial-scale biomanufacturing, our instruments are being deployed within, or adjacent to, our customers' GMP-regulated processes. While Refeyn is not itself required to hold GMP certification, this shift requires a comparable level of rigor, traceability and control discipline to that expected of a qualified GMP supplier — spanning supplier/vendor qualification, change control and notification of change, calibration traceability, complaint handling and CAPA, and data integrity controls on instrument software and outputs. This role is accountable for building and embedding those controls so that Refeyn can operate credibly as a supplier of record into GMP and GMP-adjacent environments, without over-rotating the business into the cost and rigidity of full GMP certification. The Director will manage an internal RAQA team and relationships with external consultants/contractors, as necessary to support RA/QA activities and responsibilities and provide leadership and guidance to the organization on global regulatory and quality matters. The role will drive, promote, and embed a culture of ethics, integrity and continuous improvement focused on delivering quality, compliant products and services to our customers. Reporting to our VP of Operations, this role is pivotal in growing the business whilst maintaining our customer focus through developing, implementing and improving our eQMS, regulatory strategy, processes and procedures. To ensure companywide buy-in and active ownership of the QMS and regulatory requirements, the role requires a person with a comprehensive set of change management skills, experiences, and past successes, combined with openness to learn, adapt and grow with our business. The role will be based at Refeyn's location in Oxford, UK, with a global reach in line with our company footprint and the customer base. The role will demand global travel to our customers, suppliers and office in Boston, USA. **Responsibilities** **Regulatory Affairs** - Develop, implement and manage Refeyn's global regulatory strategy to ensure compliance with applicable general product regulations (e.g. CE/UKCA marking under EMC and Low Voltage Directives, FCC/IC, RoHS, WEEE, REACH) across target markets. - Own product labelling, technical documentation and declarations of conformity required for lawful sale as a research/laboratory instrument in each target market. - Own export control classification (e.g. ECCN/customs codes) and associated compliance for international shipping of instruments and components. - Monitor evolving customer use-cases, claims and markets to determine if or when medical device, IVD, or other regulated-product frameworks (e.g. FDA, EU MDR/IVDR, NMPA medical device registration) would begin to apply to any part of the product portfolio, and advise the Executive Leadership Team accordingly. - Manage regulatory agents/distributors and associated registration renewals across global markets. - Keep abreast of industry developments, forthcoming regulations, guidance, and best practices, and translate these into actionable regulatory and quality strategy **Quality Management & eQMS** - Own and administer Refeyn's eQMS, ensuring it meets standards required by US, EU, NMPA and other major regulatory authorities for research, development and commercial activities. - Develop, implement and manage Refeyn's Quality Management System to enable quality improvements of our products and services at the speed and agility of a rapidly growing, high-tech company. - Lead the company in the drive for ISO 9001:2015 accreditation. ISO 13485 is not currently required (product is not a medical device/IVD) but should be monitored as an option if the product scope or customer requirements change. - Implement, own and improve a business process for quality improvements that prioritises customer feedback and manufacturing performance into further product and process development activities. - Ensure quality metrics comply with best industry standards and practices. - Ensure overall Quality oversight across the full value chain, from R&D, Sales and Marketing, Supply Chain and Manufacturing to Customer Support and Service, including installation and technical service activities. - Accountable for supplier/vendor qualification and a risk-based audit and inspection program. **Bioprocessing/GMP-Adjacent Customer Controls** - Build and own a framework of GMP-grade controls appropriate to a non-GMP-certified supplier serving bioprocessing and industrial biomanufacturing customers, without requiring full GMP certification of Refeyn itself. - Own the supplier/vendor qualification relationship with GMP customers, including hosting customer audits and responding to vendor qualification questionnaires. - Establish and administer a formal change control and notification-of-change (NOC) process for changes that could affect a customer's validated process (e.g. firmware, components, calibration methodology). - Support customer IQ/OQ/PQ activities with appropriate documentation, protocols and technical input, even where Refeyn does not perform validation directly. - Ensure data integrity and audit-trail controls on instrument software and outputs are aligned with ALCOA+ principles and customer expectations (e.g. Part 11 / Annex 11-adjacent controls), where instrument data feeds GMP records. - Own a formal complaint handling and CAPA process that meets the standard expected by GMP-regulated customers. - Ensure calibration traceability and Certificate of Conformance/Analysis (CoC/CoA) rigor meets the standard required by customer QA organizations. - Advise the Executive Leadership Team on the trade-offs between building GMP-adjacent controls versus pursuing formal GMP certification as the bioprocessing customer base scales. **Leadership & Governance** - Lead and manage internal RAQA team with team members based across USA and UK. - Establish strong working relationships with external manufacturers of our products and assure alignment of the eQMS and technical documentation with these manufacturers. Ensure products manufactured at manufacturing partners meet company quality standards, government regulations, and customer GMP-adjacent expectations. - Plan and oversee day-to-day activities of the Quality and Regulatory Affairs function, including management of consultants/auditors as needed to ensure project and business needs are met. - Communicate significant quality and regulatory risks that may impact product suitability, market access or ongoing compliance in a timely manner to the Executive Leadership Team. - Ensure the company's vision/mission is implemented through detailed departmental / personal objectives and supported by regular management reviews. **Person Specification** **Qualifications** - 10+ years of relevant experience in Quality and/or Regulatory Affairs management within instrumentation, analytical equipment, or bioprocess equipment manufacturing businesses supplying to Biotech, Pharma, CDMO or other regulated industries. - University Degree in Life Sciences or Engineering. Equivalent combination of education. **Knowledge & Experience** - Extensive knowledge and experience of general product compliance requirements for scientific/laboratory instrumentation sold into the USA, EU, NMPA and other global markets (e.g. CE/UKCA, EMC/LVD, FCC, RoHS, WEEE, REACH, export controls). - Working knowledge of GxP-adjacent concepts and standards relevant to customers operating under GMP (e.g. ALCOA+ data integrity principles, 21 CFR Part 11 / EU Annex 11-style controls, ISO 13485, ISO 9001:2015) — not because Refeyn is required to hold these, but to credibly support customers who are. - Direct experience operating as a supplier — not the licence holder — into GMP-regulated customers: surviving customer audits, supplier quality agreements, change notification processes, and CAPA management from the supplier side. - Familiarity with GAMP 5 and computer system validation concepts where instrument software or data touches GMP records. - Demonstrated success leading cross-functional teams in the development, implementation, application, and maintenance of eQMS platforms and regulatory submission processes. - Strategic, tactical and hands-on experience managing quality and regulatory frameworks within the company and across the supply chain and partnership base. - A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members. - Experience developing future quality and regulatory leaders and implementing organizational culture. - Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills, with the ability to deal effectively across all levels of management, regulatory agencies, and customer quality organizations. - Experience of RA/QA within an innovative scientific, engineering and manufacturing environment, ideally including scale-up from academic/research customers into industrial or bioprocessing volume. - Pragmatic approach – able to judge the right level of control for a non-GMP-certified supplier, without either under-controlling or over-engineering toward unnecessary full GMP certification. **We know there is no such thing as the perfect candidate and that there is great value in transferrable skills, so please don’t feel you have to tick all of the above boxes to apply!** **Why work for Refeyn?** Compensation and core benefits - Competetive salary - 25 days annual leave per year in addition to bank holidays - Up to 7% employer matched pension contribution - Private health insurance from day one plus critical illness cover, income protection and life insurance - Give as You Earn and Cycle to Work salary sacrifice schemes. Family Friendly Benefits Refeyn offers the Enjoy Benefits Nursery Scheme to employees after 3 months, and new parents can benefit from up to 17 weeks fully paid maternity, adoption and shared parental leave, 4 weeks fully paid paternity leave, plus an annual allowance for emergency childcare. Supporting your Development All employees receive access to LinkedIn Learning which offers thousands of courses to support their personal and professional development. We also run frequent training sessions on both hard and soft skills. **Refeyn is proud to use anonymised hiring practices. Identifying information such as a candidate's name, email address, date of birth and photo will not be visible to the hiring manager when they review CVs.**