Arago Biosciences is specializing in label-free single molecule imaging and mass measurement. Backed by Oxford Science Enterprises.
About the role
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.
What they're looking for
- University Degree in Life Sciences or Engineering. Equivalent combination of education
- 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
More about this role
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...
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