Advance your career with Prollenium Medical Technologies as a Regulatory Affairs Specialist focusing on medical devices in Richmond Hill. This hybrid opportunity 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 cutting-edge healthcare solutions.Key Responsibilities:Manage regulatory submissions and documentationSupport change controls and technical file maintenanceReview product changes for regulatory complianceAssist with external audits and inspectionsPrepare ArtG applications for regulatory approvalRequirements:Bachelor's degree in Biomedical Engineering or Life Sciences2-4 years of experience in medical device regulatory affairsUnderstanding of FDA and Health Canada regulationsExperience in technical and regulatory writingAttention to detail and project management skillsSupport Prollenium's mission to innovate within the healthcare sector.

📌 Regulatory Affairs Specialist For Medical Devices (Richmond Hill)
🏢 Prollenium Medical Technologies
📍 Richmond Hill