Elevate your career as a Regulatory Affairs Specialist with Prollenium in Richmond Hill. This hybrid role involves managing regulatory projects and ensuring compliance for our cutting-edge medical devices and products.

This Specialist role reports to the Chief Regulatory, Clinical, and Medical Affairs Officer. You will prepare, review, and maintain crucial regulatory documentation for medical devices, and support submissions to Health Canada and the US FDA. You’ll collaborate with various teams to address regulatory requirements effectively.

Key Responsibilities:
• Prepare and maintain regulatory documentation for devices
• Review product changes for regulatory impact
• Support technical files and validation documentation




• Ensure compliance during regulatory audits
• Assist with ARTG applications and inspections

Requirements:
• Bachelor’s degree in Biomedical Engineering or Life Sciences
• Minimum 2–4 years of relevant experience
• Working knowledge of medical device regulations
• Strong attention to detail and writing skills
• Familiarity with ISO 13485 and quality system requirements

Leverage your regulatory knowledge to advance Prollenium’s mission of innovation in medical devices.
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📌 Regulatory Affairs Specialist Medical Devices (Ontario)
🏢 Prollenium Medical Technologies
📍 Ontario