Job Title: Regulatory Consultant
Salary: Up to £65,000 DOE
Location: United Kingdom - Remote
Job Type: Permanent
If you are a seasoned Regulatory professional within the Medical Device space, this role might be for you! We’re looking for a Regulatory Consultant who can support a diverse portfolio of clients with particular expertise in medical device software (SaMD) and AI/ML technologies.
Key Responsibilities:
* Provide regulatory guidance on global submissions for medical devices, with a focus on software (SaMD) and AI-based technologies.
* Develop and implement regulatory strategies for EU MDR, IVDR, UKCA, and FDA pathways.
* Prepare and review regulatory submissions including 510(k), Technical Documentation, and Pre-Subs.
* Collaborate cross-functionally with QA, R&D, and clinical teams.
Experience and Qualifications Required:
* 3+ years of regulatory affairs experience in the medical device sector, ideally including consultancy work.
* Experience preparing and submitting 510(k), CE marking files, or UKCA documentation.
* Excellent communication and project management skills.
How to apply: Apply to e.smailes@x4lifesciences to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.