Join Vitaliti Technologies as a Quality and Regulatory Specialist focusing on medical device regulatory processes. This role demands precision and initiative in a structured environment.
Vitaliti Technologies is looking for a Quality and Regulatory Specialist to support its innovative initiatives in Kitchener, Ontario. The successful candidate will have at least five years of experience in quality management, particularly in medical device development. You'll be vital in upholding ISO 13485 standards and collaborating with technical teams to ensure compliance.
Key Responsibilities:
• Facilitate communication with regulatory bodies for licensing and trials
• Supervise quality processes in shipping, inspections, and assembly
• Ensure QMS documentation meets necessary regulatory standards
• Assist in creating standards and workflows for internal processes
• Manage updates through gap analysis of existing documentation
Requirements:
• 5+ years in quality environm...