Join Prollenium Medical Technologies as a Regulatory Affairs Specialist in Richmond Hill. This hybrid role focuses on managing regulatory projects and documentation for medical devices and cosmetic products.

In this Specialist position, you will report to the Chief Regulatory, Clinical, and Medical Affairs Officer. Your responsibilities will include preparing regulatory submissions, maintaining technical documentation, and ensuring compliance with Health Canada and US FDA requirements. Collaborating cross-functionally is essential to meet regulatory timelines and standards.

Key Responsibilities:
• Prepare and review technical regulatory documentation
• Maintain documentation for medical devices and equipment




• Support regulatory submissions for Health Canada and FDA
• Assist with audits and inspections documentation
• Coordinate regulatory documentation from manufacturers

Requirements:
• Bachelor's degree in Biomedical Engineering or related field
• 2–4 years of Regulatory Affairs experience
• Knowledge of Health Canada, US FDA, EU requirements
• Robust technical writing and organizational skills
• Experience with validation/testing documentation

Bring your regulatory expertise to Prollenium and impact the medical device landscape.
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📌 Hybrid Regulatory Affairs Specialist Prollenium (Ontario)
🏢 Prollenium Medical Technologies
📍 Ontario