Apply on Kit Job: kitjob.ca/job/2fskgl

Excel as a Quality and Regulatory Specialist within a medical device setting. Focus on regulatory compliance, documentation precision, and quality process improvements with a hands-on approach.
In this role, you will play a crucial part in supporting and enhancing regulatory processes while interacting with cross-functional teams. The ideal candidate must possess a comprehensive understanding of ISO requirements, especially ISO 13485, and exhibit superior documentation organization skills. Your attention to detail will be essential in managing regulatory communications and ensuring successful audits.
Key Responsibilities:
• Facilitate communication with regulatory bodies
• Oversee quality processes related to product releases
• Ensure QMS documentation meets regulatory standards




• Collaborate on developing and maintaining workflow standards
• Conduct gap analyses and remediation actions
Requirements:
• Minimum 5 years in a regulated quality workplace
• Engineering degree with P.Eng. designation required
• Familiarity with ISO 13485 or ISO 9001 standards
• Strong independent work and task completion abilities
• Effective communication and technical collaboration skills
Utilize your quality management skills to ensure compliance and excellence in medical device processes.
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Apply on Kit Job: kitjob.ca/job/2fskgl

📌 Specialist in Quality Management Systems (Kitchener)
🏢 Cloud DX
📍 Kitchener