We are recruiting on behalf of a client for a Quality & Regulatory Officer, Medical Devices.
Our client has 50 years of experience supporting businesses and the NHS,they are one of the biggest and most reputable providers of Medical Supplies in the UK.
* Job Title - Regulatory and Quality Officer
* Sector - Medical Devices
* Location - Liverpool
* Salary £35,000 to £39,000
* Holidays - 23 days increasing to 25 days with service
Role Summary The Quality & Regulatory Affairs Officer is a crucial dual role responsible for ensuring the company's compliance with all applicable UK device regulations, primarily the UK Medical Devices Regulations (UK MDR) and the EU Medical Device Regulation (MDR, 2017/745).
The QARA Officer will manage day-to-day Quality Management System (QMS) activities and support regulatory compliance and submissions, ensuring our range of products – both sterile and non-sterile are safe and compliant for market access.
Key Responsibilities Quality Management System (QMS)
1. Documentation Control: Maintain, update, and control all QMS documentation in accordance with ISO 13485:2016 requirements.
2. Internal Auditing: Plan and execute internal audits to schedule, identifying non conformities and tracking Corrective and Preventive Actions (CAPAs).
3. CAPA & NCR Management: Lead the Non-Conformance Report (NCR) and CAPA processes.
4. Supplier Management: Assist in qualifying and auditing suppliers, maintaining the Approved Supplier List, and ensuring supplier quality agreements are in place. 5. Training: Develop and deliver QMS and regulatory training programs for personnel across all departments.
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