Job Description
Position Overview:
The Quality and Regulatory Manager is responsible for overseeing the organisation’s quality assurance processes and ensuring full compliance with industry regulations and internal standards. This role requires a strategic approach to ensuring that the company’s products, services, and operations meet both customer expectations and legal requirements. The ideal candidate will be a proactive leader who can drive continuous improvement initiatives while ensuring compliance and quality standards are consistently maintained across the organisation.
The ideal candidate will be suited to extending the current scope of the ISO13485:2016 certification to include "Manufacturing" as the business continues to grow and Internationalise it's sales efforts.
Key Responsibilities:
Quality Assurance & Control:
1. Develop, implement, and maintain the company’s Quality Management System (QMS) to ensure adherence to industry standards (e.g., ISO, FDA, MDR).
2. Conduct internal quality audits and inspections to evaluate compliance with established quality standards, identify areas for improvement, and follow up on corrective actions.
3. Manage the lifecycle of quality processes, from initial design to final delivery, ensuring the delivery of high-quality ...