RA/QA Consultant - UK

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We’ve partnered with a Medtech company developing two innovative medical devices focused on advanced liver disease. Both products are progressing towards clinical investigation and regulatory approval. We are seeking an experienced Medical Device Quality and Regulatory Consultant to join us on a part-time basis (1–2 days per week) for an initial 12-month engagement. The successful candidate must be able to commute to West London for occasional meetings.

• Support the establishment and maintenance of a Quality Management System compliant with ISO 13485
• Lead preparation for CE marking (EU MDR) and UKCA marking
• Provide expert input and prepare documentation for clinical investigation submissions to the MHRA (UK) and, where relevant, other territories
• Review and approve technical documentation, risk management files, clinical evaluation plans/reports, and other regulatory submissions
• Advise on regulatory strategy and risk mitigation for Class IIa / IIb devices
• Support internal audits and preparation for notified body assessments

• Strong background in medical device regulatory affairs and quality assurance
• Proven experience with ISO 13485 certification processes
• Demonstrable experience preparing and submitting clinical investigation applications to the MHRA (and ideally other regulators e.g. FDA, EU notified bodies)
• Familiarity with EU MDR and UK Medical Devices Regulations
• Experience with devices in the hepatology / liver disease field is a strong advantage but not essential
• Excellent written English and attention to detail for regulatory documentation
• Ideally based in the UK, preferably in or near West London for easier site visits

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you’re successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.