Quality and Regulatory Coordinator

Medstrom; 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

Quality and Regulatory Coordinator

Castle Donington, Derbyshire

Are you passionate about quality, compliance, and continuous improvement? Would you like to play a key role in ensuring that medical devices and healthcare services meet the highest quality and regulatory standards? If so, we'd love to hear from you.

At Medstrom, we are proud to provide proven, well-evidenced products and services that support our busy customers and help make a real difference to patient outcomes.

Established in 2010, Medstrom has grown substantially while remaining patient-focused and committed to maintaining an open, supportive culture. In 2022, Medstrom became an Employee Ownership Trust (EOT), giving every employee a vested interest in the company and the opportunity to contribute to and share in our success.

We are looking for an enthusiastic and experienced Quality and Regulatory Coordinator to join our support team at our Head Office in Castle Donington.

The Benefits

• Starting salary of £35,000 - £45,000 depending on experience
• Contributory pension scheme
• 33 days’ annual leave entitlement (incl. Bank Holidays)
• Discounts and cashback on shopping, supermarkets, and holidays as part of our rewards scheme
• Salary sacrifice schemes, including Cycle to Work
• Structured training, ongoing professional development, and mentoring opportunities
• Free on-site gym for Head Office staff
• Death in Service benefit provided
• Birthday voucher
• Employee Ownership Trust (EOT) membership, with the associated benefits of having a stake in the company

The Role

In this role, working closely with the Director of Quality Assurance & Regulatory Affairs, you will support the effective operation and continual improvement of our Quality Management System (QMS), ensuring that products, processes and associated documentation comply with applicable quality and regulatory requirements.

Key responsibilities:

• Coordinate and support the processing of product, process, documentation, and other change requests
• Coordinate customer investigations, gathering relevant information from internal departments and customers
• Assist with Root Cause Analysis, action planning, and documentation of investigations
• Prepare audit documentation (internal and external), maintain audit records, and support the recording of audit findings
• Maintain Post Market Surveillance (PMS) records and associated documentation
• Support the maintenance and continual improvement of the QMS
• Work collaboratively with colleagues across the business

Hours of work: 37.5 per week, Monday - Friday, typically 8am - 4pm, based at Head Office in Castle Donington.

About You

To succeed in this role, you'll have:

Essential

• Experience working within an administrative, technical, quality, or regulated environment
• Excellent organisation and attention to detail
• Strong written and verbal communication skills
• Ability to prioritise and manage multiple tasks
• Good Microsoft Office skills
• Full UK driving licence, as some travel may be required

Desirable

• 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 a related discipline

In addition to the salary and related benefits, you will join a company that has grown extensively within the last few years and, through our unique ownership model, is continuing to grow, whilst offering great career opportunities for those who are keen to progress.

Webrecruit and Medstrom are equal opportunities employers, value diversity and are strongly committed to providing equal employment opportunities for all employees and all applicants for employment. Equal opportunities are the only acceptable way to conduct business and we believe that the more inclusive our environments are, the better our work will be