Quality & Regulatory Specialist for Medical Devices

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

Benefits offered by this job

Contributory pension scheme

33 days’ annual leave entitlement (inc

Discounts and cashback on shopping, 3

Salary sacrifice schemes, including Cy

Structured training, ongoing PD

Free on-site gym for Head Office staff

Death in Service benefit provided

Birthday voucher

Employee Ownership Trust (EOT)

Job summary

Medstrom Ltd is seeking a Quality and Regulatory Coordinator to join our Head Office in Castle Donington. This role focuses on maintaining and improving the Quality Management System to meet regulatory requirements and ensure product and process compliance.

You will work closely with the Director of Quality Assurance & Regulatory Affairs to drive investigations, change requests, and post-market surveillance, while supporting ongoing training and continuous improvement across the organization.

Qualifications

• Experience in a regulated or quality environment (medical devices or healthcare).
• Strong organizational and communication skills with attention to detail.
• Proficient in MS Office and documentation management.
• Full UK driving licence; some travel may be required.

Responsibilities

• Coordinate and support processing of product, process, documentation and change requests.
• Coordinate customer investigations and gather information from internal departments and customers.
• Assist with root cause analysis, action planning and investigation 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

Regulatory experience

Administrative skills

Attention to detail

MS Office skills

Driving licence

Education

Relevant qualification in Quality, Science, Engineering, Healthcare

Job description

Medstrom Ltd is seeking a Quality and Regulatory Coordinator to join our Head Office in Castle Donington. This role focuses on maintaining and improving the Quality Management System to meet regulatory requirements and ensure product and process compliance.

You will work closely with the Director of Quality Assurance & Regulatory Affairs to drive investigations, change requests, and post-market surveillance, while supporting ongoing training and continuous improvement across the organization.