Quality and Regulatory Specialist

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 environment (IVD, medical devices, pharma)
• ESSENTIAL: Strong understanding of quality systems and IVD regulatory frameworks
• Experience with ISO 13485, ISO 17025, or ISO 9001
• Previous regulatory affairs or QA experience
• Knowledge of document control systems
• Additional languages (especially German or French)
• Willingness to travel to our subsidiaries in Germany and France

PLEASE NOTE: Applicants must have right to work in the UK. My client is unable to sponsor or take over sponsorship of an employment Visa at this time.

If you are an experienced Regulatory Affairs candidate with IVDR regulatory expertise then please apply now!