Role: Regulatory Affairs Manager

Location: Oxfordshire, UK

Albion Rye Associates are pleased to be working in partnership with global diagnostics company in the search for a Regulatory Affairs Manager.

Playing a key role within the Global Regulatory Affairs team, the successful Regulatory Affairs Manager will work closely with executive management to ensure that all regulatory processes and requirements are followed, will play an instrumental role in the preparation and implementation of the IVDR, and will manage a team of Regulatory Affairs Associates.

This is a fantastic opportunity to join a pioneering organisation during a key stage in their company development, offering a fast-paced working environment and chance to take ownership within the regulatory function from day one.

Main responsibilities (to include but not be limited to):

• Works closely with the Head of Regulatory Affairs with regards to Company regulatory processes, leading to the timely product approval for both new and legacy products
• Works closely with the Quality Department ensuring that the Company’s Quality Management Systems (QMS) are managed and maintained in compliance with all regulatory requirements
• Responsible for providing global regulatory support to Commercial and sales teams
• Acts as the regulatory representative for internal and external audits
• Responsible for taking a central role in the preparation for and the implementation of requirements for IVD Regulations
• Provides input to R&D programs from a regulatory perspective
• Deputises for the Head of Regulatory Affairs, whenever necessary

Skills/experience:

• Scientific degree (ideally Pharmaceutical Science; Biology; Chemistry; or similar)
• 5+ years’ experience within regulatory affairs
• Proven track record of defining, implementing and maintaining Quality Management Systems
• Must have demonstratable experience of working within medical diagnostics and medical devices
• Excellent working knowledge of ISO 13485 and cGMP
• Good working knowledge of MDSAP
• In depth knowledge of IVDR and relevant industry and regulatory guidelines governing clinical trials in Europe and USA, and GLP and cGMP requirements related to the manufacture of diagnostics on a global scale
• Strong understanding of the scientific, biological and technical challenges and issues involved in developing diagnostic assays
• Strong people management experience
• Experience of conducting both internal and external quality audits
• Fluent in English. Additional languages are advantageous

Please note, we are unable to consider applicants who do not have the right to work in the UK.