Regulatory Affairs Consultant

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

Job summary

A leading company in the medical technology sector is looking for a Regulatory Consultant with expertise in medical device software and AI technologies. The ideal candidate will provide regulatory guidance, develop strategies for compliance across various platforms, and ensure successful submissions. This is a remote, permanent position that offers a competitive salary based on experience.

Qualifications

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

Responsibilities

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

Skills

Regulatory guidance

Project management

Communication

Job description

Social network you want to login/join with:

Regulatory Affairs Consultant, wakefield

col-narrow-left

Client:

X4 Life Sciences

Location:

wakefield, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

col-narrow-right

Job Views:

3

Posted:

31.05.2025

Expiry Date:

15.07.2025

col-wide

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.