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Quality and regulatory specialist

Litherland
Permanent
Kenton Black
Posted: 14 June
Offer description

Quality and Regulatory Specialist Liverpool Competitive salary up to £40,000, plus extensive benefits My client, a global medical devices company have a rare opportunity for a Quality and Regulatory Specialist to join them. As a Quality and Regulatory Specialist, you’ll play a key role in maintaining and enhancing the Quality Management System, ensuring compliance with international standards and regulations for in vitro diagnostic (IVD) medical devices. You’ll collaborate across departments, support regulatory submissions, manage product complaints, and contribute to continuous improvement initiatives. What you’ll do: •Support the QA/QARA Managers in maintaining compliance with ISO 13485, ISO 9001, and EU IVD Regulation 2017/746 •Investigate and resolve product complaints, ensuring timely and effective CAPAs •Assist with internal audits, document control, supplier approvals, and regulatory submissions •Liaise with international regulatory bodies and support global product registrations •Collaborate with R&D and QC teams to manage technical documentation and regulatory files •Promote regulatory awareness and best practices across the business The ideal candidate for the Quality and Regulatory Specialist will have: •A BSc degree or equivalent in Life Sciences, Microbiology, Biomedical Sciences, or related field •Experience in a laboratory or regulated enviro...

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