Regulatory Affairs Consultant

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

Job summary

A leading company in the medical device sector is seeking a Regulatory Affairs Consultant to join their team. The ideal candidate will have over three years of experience, particularly in software and AI technologies, providing regulatory guidance and preparing submissions. This remote position offers a competitive salary and the chance to work with a diverse portfolio of clients across global markets.

Qualifications

• 3+ years of regulatory affairs experience in the medical device sector.
• Experience with 510(k) submissions and CE marking files.
• Excellent communication and project management skills.

Responsibilities

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

Skills

Communication

Project Management

Job description

Regulatory Affairs Consultant, Basingstoke

Client:

X4 Life Sciences

Location:

Remote, United Kingdom

Job Category:

Other

Work Permit Required:

Yes

Job Views:

3

Posted:

31.05.2025

Expiry Date:

15.07.2025

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.

Note:

If you are NOT a passport holder of the country for the vacancy, you might need a work permit. Check our Blog for more information.

Bank or payment details should not be provided when applying for a job. Eurojobs.com is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Created on 31/05/2025 by JR, United Kingdom