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Role: Quality Technician
Location: Debenham, Suffolk
Hours: 40 hours per week (Monday-Friday, 8.30am-5.00pm)
Pay: 36,000+ (higher salary available based on experience)
We have an exciting opportunity for a Quality Technician to act as the company's regulatory specialist to join our R&D team, supporting innovation in medical device design and ensuring global regulatory compliance.
This role is based in rural Suffolk so you will need your own form of transport.
We are offering a negotiable salary and are open to candidates with strong regulatory experience in the medical device or healthcare industry.
Duties include:
- Supporting the design team with documentation and compliance
- Leading and authoring key technical file documents (e.g. CER, RMF, PMCF)
- Developing and executing strategies for global product registrations
- Writing procedures and templates to support regulatory activities
- Assisting the QA function, including CAPA and internal audits
- Ensuring compliance with EU MDR and UK MDR
- Supporting the development of the ISO 13485 QMS
- Contributing to packaging, labelling and IFU compliance
Requirements
Essential
- Strong understanding of EU/UK MDR and ISO 13485/14971
- Experience leading or authoring technical file content
- Knowledge of IFU, labelling and packaging regulations
- Experience with global regulatory submissions
- Excellent communication skills across departments
Desirable
- Familiarity with NHS supply chain registration
- Knowledge of IEC standards (e.g. (phone number removed), 62304, (phone number removed)
- Experience with MEDDEV 2.7.1 and clinical evaluation reports
If you think this role might be of interest but would like some more information, please contact Carl at Prime Appointments. Check out our website for contact details.
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