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Quality & Regulatory Officer

Scienceabode

Liverpool

On-site

GBP 35,000 - GBP 39,000

Full time

Today
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Job summary

A leading medical supplies company in the UK is seeking an experienced Regulatory and Quality Officer to ensure compliance with medical device regulations. The role involves managing the Quality Management System, conducting internal audits, and leading CAPA processes. Candidates should have experience in QMS documentation and training development. A degree in a relevant field and familiarity with ISO 13485:2016 are preferred. The position offers a salary range of £35,000 to £39,000 and a supportive work environment.

Benefits

23 days holidays increasing to 25 days with service

Qualifications

  • Experience in Quality Management Systems is essential.
  • Familiarity with ISO 13485:2016 required.
  • Experience in regulatory compliance for medical devices highly desirable.

Responsibilities

  • Maintain and control all QMS documentation.
  • Plan and execute internal audits.
  • Lead NCR and CAPA processes.
  • Assist in qualifying and auditing suppliers.
  • Develop and deliver training programs.

Skills

Documentation Control
Internal Auditing
CAPA Management
Supplier Management
Training Development

Education

Degree in a relevant field
Job description

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.

Apply now for further information and job description

£35000 – £39000/annum

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