Quality and Regulatory Lead
4 weeks ago
About Our Client
Michael Page (UK) is recruiting a Head of Quality Safety and Regulatory Compliance for a global, well-established manufacturing company that supplies bespoke, innovative products to highly regulated and safety-critical market sectors.
About the Role
This is a critical position within the company globally, requiring a highly regulated industry focus on quality and compliance. The Head of Quality and Regulatory will be responsible for a team covering manufacturing and external suppliers on all aspects of regulatory and quality.
Key Responsibilities
- QMS - Develop and maintain robust quality management systems ensuring statutory and contractual duties are fulfilled and exceeded. Monitor and review systems and services to continually improve quality standards.
- Provide clear, constructive regulatory advice and guidance to the organization and design regulatory strategy.
- Support and represent the Quality & Regulatory discipline in new product introduction and product development projects to ensure quality, testing, and certification are undertaken correctly.
- Ensure internal lab compliance testing is completed on an ongoing basis to ensure products meet standards.
- Collate data for technical files, including clinical evaluations, risk assessments, and other items.
- Collate data for the management review for ISO13485.
- Manage customer complaints relating to non-conforming product and ensure timely resolution and corrective action.
- Escalate updates and reports to the line manager and wider management as required.
- Notify and track regulatory and quality activities and maintain database entry/data accuracy.
- Highlight updates to regulatory requirements to senior management.
- Maintain the calibration register for testing and measuring equipment.
Requirements
The ideal candidate will be an experienced quality and regulatory professional with a working knowledge of ISO9001 and MDD / MDR. They will have experience working with Class 1 and Class 2a (sterile) Medical devices.
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