Quality & Regulatory Affairs Officer Permanent Full Time £34-40k D.O.E South Liverpool Hybrid Working
Our client, is seeking an experienced Quality & Regulatory Affairs Officer to join their team, based in beautiful modern offices in South Liverpool, working within a small, friendly and dynamic team. The successful candidate will have 2-3 years previous experience within this field, and have proven working knowledge and practical application of the requirements ofISO 13485:2016.Demonstrable understanding of the UK Medical Devices Regulations and the EU MDR (2017/745).
Key Responsibilities
Quality Management System (QMS) Compliance
* Documentation Control:Maintain, update, and control all QMS documentation in accordance withISO 13485:2016requirements.
* Internal Auditing:Plan and execute internal audits to schedule, identifying non-conformities and tracking Corrective and Preventive Actions (CAPAs).
* CAPA & NCR Management:Lead the Non-Conformance Report (NCR) and CAPA processes, ensuring thorough investigation, root cause analysis, and effective closure.
* Supplier Management:Assist in qualifying and auditing suppliers, maintaining the Approved Supplier List, and ensuring supplier quality agreements are in place.
* Training:Develop and deliver QMS and regulatory training programs for personnel across all departments.
Regulatory Affairs (RA) & Market Access
* Technical Documentation:Prepare, compile, and maintain essential elements of the Technical File (TF) and Design Dossiers, focusing on clinical data, risk management (ISO 14971), and post-market surveillance (PMS).
* UKCA & CE Marking:Support the generation of Declaration of Conformity (DoC) documents for product placement in the UK (UKCA) and EU (CE) markets.
* Regulatory Submissions:Assist in submitting regulatory applications, including UK registration, and communication with the UK MHRA, EU Notified Bodies and other global Competent Authorities (CAs), as required.
* Post-Market Surveillance (PMS) & Vigilance:Manage the PMS system, including review of post-market clinical follow-up (PMCF) activities, processing customer complaints, and assisting with adverse event reporting (Vigilance) to competent authorities.
* Standards Monitoring:Monitor changes in relevant harmonised standards (e.g.,ISO 10993, ISO 11137) and regulations, initiating QMS updates as required.
Company offer a fantastic benefit package!
For further information about this opportunity please call Forrest Recruitment Ltd for a confidential discussion 0151 255 0565. Alternatively, please forward your CV for immediate consideration, I look forward to hearing from you.
Please note that due to the high volume of applications we receive, only those successfully shortlisted for the role will be personally contacted.
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