Regulatory Affairs Consultant

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

Job summary

A leading company in the medical device sector is seeking a Regulatory Consultant to provide expert guidance on global submissions. This remote role focuses on software and AI/ML technologies in medical devices and requires a seasoned professional with relevant experience in regulatory affairs.

Qualifications

• 3+ years of regulatory affairs experience in medical devices.
• Experience with submissions like 510(k), CE marking files, or UKCA documentation.
• Excellent communication and project management skills.

Responsibilities

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

Skills

Regulatory affairs

Communication

Project Management

Job description

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Regulatory Affairs Consultant, guildford

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Client:

X4 Life Sciences

Location:

guildford, 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.