Regulatory Affairs Consultant

JR United Kingdom; Kingston upon Hull; Remote; GBP 55,000 - 65,000; Full time

Job summary

A leading company in the medical device sector seeks a seasoned Regulatory Consultant to provide expertise in regulatory affairs. The role involves guiding clients on submissions for medical device software and developing strategies for compliance with regulations such as EU MDR and FDA pathways. Applicants should have over three years of experience in the field and excellent communication skills.

Qualifications

• 3+ years of regulatory affairs experience in the medical device sector.
• Experience with 510(k), CE marking files, or UKCA documentation.

Responsibilities

• Provide regulatory guidance on global submissions for medical devices.
• Develop and implement regulatory strategies for EU MDR, IVDR, UKCA, and FDA pathways.
• Collaborate cross-functionally with QA, R&D, and clinical teams.

Skills

Regulatory guidance

Communication

Project management

Job description

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Regulatory Affairs Consultant, kingston upon hull, east yorkshire

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Client:

X4 Life Sciences

Location:

kingston upon hull, east 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.