Description
IVD Regulatory Consultant
Are you an expert in IVD regulation looking for a fresh challenge with broad exposure and autonomy? We are recruiting several consultants to support rapidly growing medical innovation projects across the UK, EU, and US. Candidates with regulatory and ideally QA expertise, especially hands-on with FDA and IVDR requirements, are strongly encouraged to apply.
The Role:
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Lead and support the preparation of regulatory submissions for IVD products under FDA (510[k], PMA) and IVDR (EU) frameworks.
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Advise clients on strategy for global compliance, including CE and UKCA marking pathways.
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Prepare and review technical documentation, regulatory files, and responses to regulatory authority queries.
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Act as a subject matter expert for independent client projects and ongoing compliance support.
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If you have experience in quality management (ISO 13485, 21 CFR 820), you will take a key role in implementing or upgrading client QMS and supporting audits or inspections.
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Fully remote role, UK-based, with client travel as required.
Requirements:
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Strong working knowledge of IVDR regulatory processes and FDA submissions for IVDs.
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Hands-on experience preparing, reviewing, and submitting technical files and regulatory documents.
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Any experience with ISO 13485 quality management, audit support, or QA process improvement is a distinct advantage.
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Ability to work independently, manage your own priorities, and communicate confidently with varying technical and leadership audiences.
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Professional approach and strong attention to detail.
What’s on Offer:
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£40,000 to £70,000 salary depending on experience.
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Home based with all travel expensed as required.
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Freedom, variety, and autonomy; you will work on a range of innovative diagnostics projects.
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Supportive, expert-led team and real opportunities for ongoing professional growth.
If you are ready to make a genuine impact on breakthrough IVD technologies and want flexibility and challenge in your next move, please apply with your CV or reach out to discuss confidentially.