Quality & Regulatory Specialist – Medical Devices

Medstrom Ltd; East Midlands; On-site; GBP 35,000 - 45,000; Full time

Benefits offered by this job

Pension scheme

33 days’ annual leave

Discounts and cashback

Cycle to Work

Training and mentoring

On-site gym

Death in Service

EOT membership

Job summary

Medstrom Ltd is seeking a Quality and Regulatory Coordinator to join the Head Office team in Castle Donington. You will help operate and continually improve the QMS, ensuring products and documentation meet quality and regulatory requirements.

You will work with the Director of Quality Assurance & Regulatory Affairs to coordinate change requests, investigations, and audit documentation, while maintaining PMS records and driving continual improvement across the business.

Qualifications

• Experience in administrative, technical, quality or regulated environments.
• Knowledge of ISO 13485.
• Knowledge of CAPA and non-conformance processes.
• Medical device, healthcare, or manufacturing experience.
• Relevant qualification in Quality, Science, Engineering, Healthcare, or related discipline.

Responsibilities

• Coordinate and support processing of product, process, documentation and change requests.
• Coordinate customer investigations with internal departments and customers.
• Assist with Root Cause Analysis, action planning and investigations documentation.
• Prepare internal and external audit documentation and maintain audit records.
• Maintain Post Market Surveillance (PMS) records and related documentation.
• Support maintenance and continual improvement of the QMS.
• Collaborate with colleagues across the business.

Skills

Quality management

Regulatory compliance

Documentation

CAPA

Audit support

Communication

Organisation

Education

Quality/Engineering/Healthcare related qualification

Job description

Medstrom Ltd is seeking a Quality and Regulatory Coordinator to join the Head Office team in Castle Donington. You will help operate and continually improve the QMS, ensuring products and documentation meet quality and regulatory requirements.

You will work with the Director of Quality Assurance & Regulatory Affairs to coordinate change requests, investigations, and audit documentation, while maintaining PMS records and driving continual improvement across the business.