Regulatory Quality Specialist

Enhance regulatory quality processes at Vitaliti Technologies as a Quality Specialist. This role demands attention to regulatory compliance in medical device environments within Kitchener, Ontario.

We are looking for a self-driven Quality and Regulatory Specialist with over five years in quality management. You’ll interact with cross-functional teams and regulatory bodies while maintaining compliance with rigorous standards like ISO 13485. The position requires a proactive individual who excels in recognizing documentation gaps and ensuring continuous improvement in quality systems.

Key Responsibilities:

• Facilitate communications with North American and EU regulatory bodies

• Oversee quality processes from shipping to product release

• Ensure QMS aligns with regulatory compliance standards

• Develop standards and workflows within the QMS

• Support audits and assess compliance with quality standards

Requirements:

• 5+ years in a regulated quality management setting

• Engineering degree with P.Eng. designation

• Practical QMS maintenance experience

• Knowledge of ISO 9001 and 13485

• Strong written and verbal communication skills

Apply your quality management expertise to uphold Vitaliti's high standards and compliance in medical device development.
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