Regulatory Affairs Co-op

Regulatory Affairs Co- op (Hybrid)

Term: May 2025

Duration: 4 months, with the possibility of extension

Openings: 1 position

Salary Range: $3,650 - $4,525 CAD per month

Application Deadline: Friday, January 17, 2025

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.

As part of the Regulatory Affairs team, you will gain experience in the development and application of systems used to ensure that the company is able to comply with the regulatory requirements of agencies such as Health Canada and the US Food and Drug Administration. This role provides exposure to the strategic elements of bringing a medical device to the market, which develops skills that are transferable to many other regulated industries. You will also be exposed to the many departments of the company such as Quality, Engineering, Manufacturing, etc. in order to properly interpret relevant regulations and literature.

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

Meaningful work you will be a part of

You will engage in activities that develop practical and transferable skills such as:

• Participate in research and collection of data related to regulatory issues and emerging scientific topics to help develop regulatory strategies
• Coordinating collection of information and preparation of regulatory documentation for submission to regulatory agencies
• Assisting with the implementation and maintenance of systems for tracking submissions, and changes thereof, sent to regulators and partners
• Maintaining regulatory files, databases, and chronologies in adequate order
• Assisting with tracking and trend analysis of productivity, timeliness, and quality metrics
• Assisting in other regulatory, quality, and operational tasks as required
  
  

What You Bring To The Team

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable.

You will be successful in this role because you possess these attributes:

• A basic understanding of public administration
• An interest in reading and report writing, with an inquisitive nature
• Excellent written and verbal communication
• Excellent technical documentation skills
• Experience with data entry
• Strong organizational skills
• Be highly proactive and able to execute tasks with minimal instruction and guidance
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook), Adobe Acrobat, and SmartSheets is ideal
  
  

Why work at Kardium?

A meaningful Co-op/Intern term experience, working with truly innovative technology and an ambitious team, combined with:

Making a Difference: Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide.

Meaningful Work: Gain hands on experienceworking on projects that make an impact, giving you valuable experience to kickstart your career.

Team Bonding Events: Connect with peers (of 30+ Co-ops) and participate in fun team activities, social events, and monthly Co-op events.

Development & Growth: Collaborating with engaged leaders and multi-disciplinary teams who are committed to your success by mentoring and supporting your development and growth.

Innovative Projects: Be part of cutting-edge projects where you can share your ideas and learn new skills in a fast-paced environment.

Life at Kardium

What makes us a great place to work?

• Our Purpose
• Our People
• Our Culture
  
  

At Kardium, we embrace diversity of background, experience, and perspective and we’re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.

We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs 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, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.

And our employees think we are great too – check out Glassdoor to learn more!

How To Apply

To apply for this position, please upload three separate documents in PDF format via our Careers Page :

• Cover letter
• Resume
• Most recent transcripts (to be combined in one PDF document)
  
  

Please note, there are also required questions to be completed, as a part of your overall application.

Apply Now