Regulatory Affairs & Quality Assurance Director

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 s