Website Frossell Recruitment
To apply for this job email your details to bianca@frossellrecruitment.co.uk.
Regulatory Affairs Specialist
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About the Author: Bianca Frossell
Fully Remote
Permanent
Competitive Salary + Excellent Benefits
An established and growing organisation in the scientific technology sector is seeking a Regulatory Affairs Specialist to support ongoing product compliance and regulatory processes in line with UK and international regulations.
This is a fantastic opportunity to work in a collaborative, forward-thinking environment where your expertise will directly impact patient safety, product quality, and operational compliance
Key Responsibilities
- Prepare, analyse, and maintain technical and regulatory documentation for product submissions.
- Support product registrations, post-market surveillance, and safety corrective actions.
- Liaise with regulatory authorities and respond to queries within agreed timelines.
- Support audits, inspections and quality system updates.
- Help build and continuously improve regulatory frameworks and internal processes.
- Contribute to cross-functional initiatives across quality, product and operations teams.
What We’re Looking For:
- Experience in a regulatory affairs role, ideally within life sciences, diagnostics or medical devices.
- Scientific/technical degree (Biology, Biomedical, Chemistry, or similar).
- Strong communication and collaboration skills with attention to detail.
- Experience with quality systems, documentation and regulatory submissions
- Experience in IVD, laboratory technology, or clinical diagnostics.
- Familiarity with UK Responsible Person duties or REACH compliance.
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