Regulatory Affairs Consultant

JR United Kingdom; Gloucester; Remote; GBP 55,000 - 65,000; Full time

Job summary

A leading company in the medical device sector is seeking a Regulatory Consultant to support clients with expertise in software and AI technologies. This permanent, remote role requires significant experience in regulatory affairs, particularly with 510(k) and CE marking processes. You will play a key role in developing strategies for compliance and regulatory submissions across diverse markets.

Qualifications

• Experience in medical device sector, ideally consultancy.
• Experience preparing 510(k), CE marking, and UKCA documentation.

Responsibilities

• Provide regulatory guidance on global submissions.
• Develop and implement regulatory strategies for EU MDR, IVDR, UKCA, and FDA.
• Prepare and review regulatory submissions.

Skills

Communication

Project Management

Education

3+ years regulatory affairs experience

Job description

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Regulatory Affairs Consultant, gloucester

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Client:

X4 Life Sciences

Location:

gloucester, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

31.05.2025

Expiry Date:

15.07.2025

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Job Description:

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.