Join Kardium as a Regulatory Affairs Specialist in Burnaby, BC, and help transform healthcare with creative 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 robust 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 changes
Collaborate with Engineering and Quality teams on regulatory needs




Review risk assessments and documentation for compliance
Maintain clear regulatory records and facilitate submissions
Monitor changing global regulatory landscapes

Requirements:
Bachelor’s degree in a technical field
Experience in Regulatory Affairs or Quality Assurance
Familiarity with international medical device regulations
Proficiency with electronic quality management systems
Robust detail-oriented organizational skills

Support Kardium’s mission by applying your regulatory expertise and enhancing patient care.
J-18808-Ljbffr

📌 Regulatory Affairs Specialist Hybrid Position Burnaby
🏢 Kardium
📍 Burnaby