Quality & Regulatory Affairs Officer

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 with ISO 13485:2016 requirements.
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

. 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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