Regulatory Compliance Coordinator

4 weeks ago


Castle Donington, Leicestershire, United Kingdom Medstrom Full time
Job Description

Your Role:

- Implement and maintain our ISO 13485 quality management system (QMS) to ensure compliance with regulatory requirements.
- Develop, review, and revise quality system documentation, including procedures, work instructions, and forms.
- Manage and maintain quality records, ensuring accuracy, completeness, and accessibility.
- Conduct internal audits to identify and address potential non-conformances in the QMS.
- Prepare for external audits by regulatory bodies.
- Analyze quality data and participate in corrective and preventive action (CAPA) activities.
- Stay up-to-date on regulatory requirements for medical devices, including ISO 13485 and relevant regional regulations.



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