Quality and Regulatory Affairs Lead at Somagen

Join Somagen Diagnostics as a Quality and Regulatory Affairs Lead in Mississauga. Oversee regulatory compliance, quality management systems, and enhance operational capabilities in the healthcare sector.

This managerial position focuses on setting strategic objectives for regulatory affairs and quality controls within Canada’s largest independent provider of diagnostic solutions. Your leadership will be crucial in integrating a Quality Management System and achieving ISO certification while ensuring product compliance and safety. Collaborate effectively across functions to streamline processes and foster a culture of quality excellence.

Key Responsibilities:

• Manage regulatory records and compliance standards

• Develop ISO-oriented Quality Management System

• Support regulatory communications and market access strategies

• Oversee quality metrics and continuous improvement initiatives

• Lead and develop staff in regulatory and quality roles

Requirements:

• Background in medical device Regulatory Affairs and Quality

• Familiarity with Health Canada Medical Devices Regulations

• Experience in QMS development and ISO standards

• Proven leadership and project management capabilities

• Excellent communication and decision-making skills

Lead quality and regulatory processes that enhance healthcare outcomes at Somagen.