Elevate your career at Somagen Diagnostics as a Regulatory Affairs and Quality Manager in Mississauga. Lead compliance, quality management system development, and ensure regulatory excellence across the Canadian market. In this pivotal role, you will oversee all regulatory functions and quality assurance for Somagen, which serves as Canada’s premier diagnostic technology provider.

You will lead teams to implement ISO standards and enhance quality metrics, while directly influencing product compliance and market readiness. Engage and collaborate with various departments to establish a comprehensive operating model for regulatory affairs and quality management. Key Responsibilities:

- Own MDEL governance and Health Canada compliance




- Lead development of the Quality Management System
- Advise teams on regulatory requirements and product changes
- Manage inspections, recalls, and audits
- Build and mentor Regulatory and Quality teams Requirements:
- Extensive experience in Regulatory Affairs and Quality
- Knowledge of Health Canada regulations
- Expertise in QMS design and ISO certification processes
- Proven leadership in quality processes
- Solid communication and analytical skills Drive regulatory integrity and quality standards at Somagen to support healthcare advancements.

📌 Regulatory and Quality Manager - Somagen Diagnostics (Mississauga)
🏢 Diploma Healthcare Group
📍 Mississauga