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Medical Device Regulatory Compliance Specialist

1 week ago

Burnaby, British Columbia, Canada Kardium Full time
About Us
Kardium is a leading developer of innovative medical devices, committed to delivering cutting-edge solutions for patients worldwide. Our mission is to deliver the best treatment for atrial fibrillation, and we have developed The Globe Pulsed Field System – a fantastic technical achievement that has strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

Job Summary
We are seeking a highly skilled Regulatory Affairs Project Manager to join our team at Kardium. This role involves managing multiple projects simultaneously through all phases of the project life cycle, ensuring that regulatory compliance is maintained, and collaborating with cross-functional teams to develop and maintain systems required to support regulatory documentation, submissions, and operations.

Main Responsibilities
- Manage multiple projects concurrently through all phases of the project life cycle, including planning, scheduling, budgeting of resources, project controls, risk management, and reporting
- Ensure regulatory compliance is maintained through effective project management
- Collaborate with cross-functional teams to develop and maintain systems required to support regulatory documentation, submissions, and operations
- Develop and implement project plans that include schedules, activities, deliverables, dependencies, milestones, risks, and issues
- Communicate effectively with stakeholders to ensure timely project completion

Requirements
This role requires a Bachelor of Science or Engineering degree and a minimum of three years of relevant Regulatory Affairs experience or equivalent combination of post-graduate education and experience with at least one year in a leadership position. Experience with high-risk medical devices, In-Vitro Diagnostics, or pharmaceuticals is also essential. Strong time management skills, ability to take initiative, and uphold project timelines by holding relevant parties accountable are necessary. An in-depth working knowledge of European, US, and Canadian medical device regulatory requirements is an asset.

Benefits
Kardium offers a comprehensive benefits package, including competitive salary, RRSP contributions, comprehensive medical & dental coverage, flexible work arrangements, career progression opportunities, professional membership support, family building support, and more.