Compliance Specialist; Hybrid

Overview

By joining the Kardium team you will help make a difference in the lives of millions worldwide. Kardium has developed The Globe® Pulsed Field System, a ground‑breaking medical device for the diagnosis and treatment of atrial fibrillation. The company has completed its pivotal clinical study and is focused on regulatory approvals and commercial launch.

Kardium is seeking a Compliance Specialist to join the Quality Assurance/Regulatory Affairs (QA/RA) Team. The role reports to the Senior Manager, Compliance and supports the maintenance of Kardium’s Quality Management System (QMS). This is a hybrid position located in Burnaby, BC.

• Provide QA support to Clinical Operations, including vendor and site audits.
• Act as a member of the internal audit team, performing QMS audits, preparing reports, and following up on corrective actions.
• Maintain Kardium Clinical Studies and Commercial Safety Databases.
• Assist with supplier qualification and monitoring activities, including site audits as required.
• Support external audits and regulatory inspections.
• Help develop and assess QMS performance metrics.
• Deliver QMS onboarding training.
• Perform other QA tasks as needed.

• Master’s degree in a technical or science field, or equivalent combination of education and experience.
• Three to five years in a manufacturing, QA, or testing environment.
• Experience in Clinical QA and ISO 14155/GCP compliance is highly desirable.
• Strong knowledge of ISO 13485, FDA QMSR, and MDR 2017/745.
• Lead auditor certification in ISO 13485 is an asset.
• Experience with electronic document and record management systems.

• Strong analytical and critical thinking skills.
• Effective written and verbal communication and technical documentation skills.
• Proficiency in MS Office, Access, and Excel.
• Organized and detail‑oriented.
• Excellent interpersonal skills.
• Willingness to travel occasionally.
• Flexible and adaptable to take on additional responsibilities.

$70,000 – $100,000 CAD annually, plus a contribution to a Registered Retirement Savings Plan (RRSP).

• Comprehensive medical & dental coverage effective Day 1.
• Work‑day flexibility and 3 personal days per year.
• Support for overall well‑being and professional membership.
• Family building benefits: top‑up for maternity and adoptive leave, fertility drug coverage.
• Career progression and learning support.

• Our Purpose
• Our People
• Our Culture

Kardium embraces diversity of background, experience, and perspective and is committed to inclusion and equity at every level. All qualified candidates from diverse communities are encouraged to apply.

We collaborate with Employee Resource Groups (ERGs). Examples include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Brazilian ERG, and Irish ERG.

As part of your application, please note if you require an accommodation for the recruitment process (e.g., alternate formats, accessible meeting rooms). An optional section in the application form allows you to provide this information to the recruitment team.

Learn more about life at Kardium on Glassdoor.