Compliance Specialist (Hybrid)

About the job

Your opportunity By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.

Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – we have a fantastic technical team that has developed a product with 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.

We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.

Kardium has a unique opportunity for a Compliance Specialist. As a member of the Quality Assurance/Regulatory Affairs (QA/RA) Team, the Compliance Specialist will provide support to the maintenance of Kardium’s Quality Management System (QMS). The position reports to the Senior Manager, Compliance.

Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC.

What You’ll Be Doing Your responsibilities will include:

• Providing QA support to Clinical Operations, including vendor and site audits
• Acting as a member of the internal audit team performing audits of the QMS system, including assisting with planning, preparing reports, and other audit documentation, and performing follow-up activities
• Maintaining Kardium Clinical Studies and Commercial Safety Databases
• Assisting with supplier qualification and monitoring activities, including site audits, as required
• Assisting with external audits and regulatory inspections
• Assisting with development and assessment of QMS performance metrics
• Delivering QMS onboarding training
• Performing any other QA tasks as required

What You Bring To The Team Our Kardium team is smart, creative, and passionate about developing cutting-edge medical devices to help improve people’s lives. We work in a collaborative environment based on trust and respect. We understand that only by working together can we solve what was thought unsolvable.

You are suited to our approach and possess these attributes:

Education & Experience

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

Skills

• Strong analytical skills and critical thinking
• Effective written and verbal communication and technical documentation skills
• Strong computer skills (MS Office, Access, Excel)
• Organized and detail-oriented
• Excellent interpersonal skills
• Willingness to travel occasionally
• Flexible and adaptable to take on additional responsibilities as appropriate