Regulatory Affairs Consultant

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

Job summary

Une entreprise de sciences de la vie recherche un Consultant Réglementaire pour soutenir un large portefeuille de clients, avec une expertise dans les logiciels de dispositifs médicaux et les technologies basées sur l'IA. Le poste est permanent, avec un salaire allant jusqu'à 65 000 £ en fonction de l'expérience. Le candidat idéal aura plus de 3 ans d'expérience dans ce domaine et sera responsable de la stratégie réglementaire pour divers marchés.

Qualifications

• 3+ ans d'expérience en affaires réglementaires dans le secteur des dispositifs médicaux.
• Expérience de préparation et de soumission de dossiers 510(k) et documentation UKCA.

Responsibilities

• Fournir des conseils réglementaires sur les soumissions globales pour les dispositifs médicaux.
• Préparer et examiner les soumissions réglementaires, y compris les 510(k) et la documentation technique.

Skills

Communication

Project Management

Job description

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Regulatory Affairs Consultant, liverpool

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Client:

X4 Life Sciences

Location:

liverpool, 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.