Regulatory Affairs Consultant

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

Job summary

A leading company is seeking a Regulatory Consultant with extensive experience in medical devices to provide regulatory guidance and develop strategies for various submissions, including software. This remote position offers an exciting opportunity for professionals looking to advance their career in a growing sector.

Qualifications

• 3+ years in regulatory affairs in the medical device sector, including consultancy.
• Experience with 510(k), CE marking, or UKCA submissions.
• Strong communication and project management skills.

Responsibilities

• Provide regulatory guidance for medical devices, focused on software and AI technologies.
• Develop regulatory strategies for EU MDR, IVDR, UKCA, and FDA.
• Prepare and review submissions for 510(k) and Technical Documentation.

Skills

Regulatory affairs

Project management

Communication

Job description

Social network you want to login/join with:

col-narrow-left

Client:

X4 Life Sciences

Location:

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.