Regulatory Affairs & Quality Assurance Director

📋 Description

• Develop, implement and manage Refeyn's global regulatory strategy to ensure compliance with
• Own product labelling, technical documentation and declarations of conformity required for lawful
• Own export control classification (e.g. ECCN/customs codes) and associated compliance for
• Monitor evolving customer use-cases, claims and markets to determine if or when medical device
• Manage regulatory agents/distributors and associated registration renewals across global markets.
• Keep abreast of industry developments, forthcoming regulations, guidance, and best practices, and

🎯 Requirements

• 10+ years of relevant experience in Quality and/or Regulatory Affairs management within
• University Degree in Life Sciences or Engineering. Equivalent combination of education.
• Extensive knowledge and experience of general product compliance requirements for
• Working knowledge of GxP-adjacent concepts and standards relevant to customers operating under GMP
• Direct experience operating as a supplier — not the licence holder — into GMP-regulated customers
• Familiarity with GAMP 5 and computer system validation concepts where instrument software or data

🎁 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
• Give as You Earn and Cycle to Work salary sacrifice schemes
• Refeyn offers the Enjoy Benefits Nursery Scheme to employees after 3 months, and new parents can