Regulatory Affairs Consultant

JR United Kingdom; Sheffield; Remote; GBP 50,000 - 65,000; Full time

Job summary

A leading consulting firm seeks a Regulatory Consultant to provide expert regulatory guidance in medical devices. This permanent role involves developing compliance strategies for various regulatory pathways in the medical device sector, particularly focusing on software and AI technologies. The ideal candidate will have over three years of regulatory experience and a track record of successful submissions.

Qualifications

• 3+ years of regulatory affairs experience in the medical device sector.
• Experience preparing and submitting 510(k) and UKCA documentation.
• Excellent communication and project management skills.

Responsibilities

• Provide regulatory guidance on global submissions for medical devices.
• Develop regulatory strategies for EU MDR, IVDR, UKCA, and FDA pathways.
• Prepare and review regulatory submissions including 510(k) and Technical Documentation.

Skills

Regulatory guidance

Project management

Communication

Job description

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Regulatory Affairs Consultant, sheffield, south yorkshire

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Client:

X4 Life Sciences

Location:

sheffield, south yorkshire, 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.