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Current Openings

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    <h1 class="job-title">Compliance Specialist - Medical Device Reporting (Hybrid) - 18 Month Leave Coverage</h1>\n    <h3 class="job-location"><a target="_blank" href="https://maps.google.com/maps?q=Burnaby%2C%20British%20Columbia%2C%20Canada&zoom=14&size=512x512&maptype=roadmap&sensor=false">Burnaby, British Columbia, Canada</a></h3>\n    <div class="job-content">\n

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Your opportunity

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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 minimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other heart-related complications.

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Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

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Kardium has a unique opportunity for an experienced Medical Device Reporting (MDR) Compliance Specialist. As a member of the QA team, the MDR Compliance Specialist will be responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Kardium products in accordance with applicable internal procedures, regulations and regulatory guidance worldwide.

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

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What you’ll be doing

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Your responsibilities will include:

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• Coordinate the development, implementation and improvement of internal QMS processes and methods to maintain MDR/vigilance compliance and support post-market surveillance
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• Assemble and coordinate a cross-functional Review Board, comprising representatives of the Regulatory Affairs, Clinical Affairs, and Quality Engineering teams, to collaboratively review and investigate customer complaints and adverse events reported to Kardium, in order to meet regulatory obligations
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• Assess complaint files for completeness and correctness, and communicate with Kardium field personnel, health care providers, and patients to gather additional information as required
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• Liaising with Quality Engineering, Kardium field personnel, and/or customers as appropriate, to ensure that complaints, adverse events and product malfunctions are investigated within the timeframes required by applicable regulations and regulatory guidance.
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• Provide subject-matter expertise to support the Complaint Review Committee (CRC)’s decision-making process
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• Ensure that the results of investigations and determinations made by the Review Board, including reportability decisions, are accurately documented, and that meeting minutes are recorded and action items are assigned/completed, as required. Ensure all required records are complete and accurate, and have been reviewed/approved by appropriate stakeholders, including incident reports, recall reports, and recall status reports
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• Assist Regulatory Affairs with preparing and managing applicable reports to regulatory agencies, in accordance with regulatory requirements, and with preparing responses to queries from regulatory agencies, as required
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• Collaborate with Regulatory Affairs to escalate issues requiring additional input and oversight by Kardium executive management representatives, as needed
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• Assist with the planning, implementation and effectiveness verification of corrective and preventive actions
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• Provide necessary support and training to employees, to ensure compliance with all applicable standards and regulations
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• Coordinate complaint and adverse event data collection for trending purposes, and assist with preparing periodic trend reports for complaints and adverse events as required
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• Support internal and external audits and inspections, as required
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What you bring to the team

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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.

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Education & Experience

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• Bachelor’s degree in Health Care, Health Sciences or Bio-Medical Engineering or equivalent combination of education and highly relevant experience.
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• At least 2 years’ hands-on experience with medical device reporting or complaint handling.
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• Strong, in-depth, working knowledge of medical device reporting requirements in ISO 13485, U.S. CFR, European MDD and MDR, and relevant regulatory guidance documents.
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• Experience with electronic document and electronic record management systems.
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Skills

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• Strong analytical skills and critical thinking
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• Effective written & verbal communication and technical documentation skills
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• Excellent computer skills (MS Office, Excel) 
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• Able to operate independently with minimal direction
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• Organized and detail-oriented
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• Excellent interpersonal skills including the ability to resolve conflict with poise, diplomacy and tact
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• Ability to work effectively as part of a team and collaborate with staff at all levels
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• Flexible and adaptable to take on additional responsibilities as appropriate
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Why work at Kardium

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A meaningful career working with a truly innovative technology and an ambitious team, combined with:

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• Knowing every day that you are making a difference in people’s lives by helping treat a condition that affects millions worldwide
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• A great working environment with opportunities to develop your skills and knowledge
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• An opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
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• An engaged leadership team who believes in mentoring and growing employees’ careers
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• Supportive and fun colleagues with plenty of social events to encourage people connections
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• And our employees think we are great too – check out Glassdoor to learn more! \n
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Thanks in advance for your interest in Kardium!

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