Regulatory Affairs Consultant

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Regulatory Affairs Consultant, United Kingdom

Client:

X4 Life Sciences

Location:

United Kingdom - Remote

Job Category:

Other

EU work permit required:

Yes

Job Views:

6

Posted:

24.04.2025

Expiry Date:

08.06.2025

Job Description:

Job Title: Regulatory Consultant

Salary: Up to £65,000 DOE

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:

1. Provide regulatory guidance on global submissions for medical devices, with a focus on software (SaMD) and AI-based technologies.
2. Develop and implement regulatory strategies for EU MDR, IVDR, UKCA, and FDA pathways.
3. Prepare and review regulatory submissions including 510(k), Technical Documentation, and Pre-Subs.
4. Collaborate cross-functionally with QA, R&D, and clinical teams.

Experience and Qualifications Required:

1. 3+ years of regulatory affairs experience in the medical device sector, ideally including consultancy work.
2. Experience preparing and submitting 510(k), CE marking files, or UKCA documentation.
3. 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.