Advance your career with Prollenium Medical Technologies as a Regulatory Affairs Specialist focusing on medical devices in Richmond Hill. This hybrid chance combines project oversight and regulatory compliance.

As a Regulatory Affairs Specialist, you will manage submissions and documentation for Class I-III medical devices while supporting cosmetic product initiatives. Collaborate across teams to ensure all regulatory requirements are met, including those from Health Canada, EU, and US FDA. Your meticulous approach and regulatory expertise will drive compliance and facilitate the successful launch of innovative healthcare solutions.

Key Responsibilities:
• Manage regulatory submissions and documentation
• Support change controls and technical file maintenance




• Review product changes for regulatory compliance
• Assist with external audits and inspections
• Prepare ArtG applications for regulatory approval

Requirements:
• Bachelor’s degree in Biomedical Engineering or Life Sciences
• 2-4 years of experience in medical device regulatory affairs
• Understanding of FDA and Health Canada regulations
• Experience in technical and regulatory writing
• Attention to detail and project management skills

Support Prollenium's mission to innovate within the healthcare sector.
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📌 Regulatory Affairs Specialist for Medical Devices (Ontario)
🏢 Prollenium Medical Technologies
📍 Ontario