Join Kardium as a Regulatory Affairs Specialist in Burnaby, BC, and help transform healthcare with cutting-edge solutions. This hybrid role focuses on regulatory change control and assessment.In this pivotal position, you will assess changes across product design, manufacturing, and labeling while collaborating with cross-functional teams. Ideal candidates will possess a strong technical background, preferably in mechanical or electrical engineering, combined with experience in Regulatory Affairs within the medical device field.



Your role will ensure safety and compliance in the launch of groundbreaking medical technology.Key Responsibilities:Conduct regulatory assessments for proposed changesCollaborate with Engineering and Quality teams on regulatory needsReview risk assessments and documentation for complianceMaintain clear regulatory records and facilitate submissionsMonitor changing global regulatory landscapesRequirements:Bachelor's degree in a technical fieldExperience in Regulatory Affairs or Quality AssuranceFamiliarity with international medical device regulationsProficiency with electronic quality management systemsStrong detail-oriented organizational skillsSupport Kardium's mission by applying your regulatory expertise and enhancing patient care.

📌 Regulatory Affairs Specialist Hybrid Position (Burnaby)
🏢 Kardium
📍 Burnaby