298 Regulatory Affairs Specialist

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground-breaking medical device for the diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

As a Regulatory Affairs (RA) Specialist, you will work with the RA Team to bring innovative and highly complex medical devices to the market and maintain their regulatory compliance. The role will involve coordinating submissions for market authorizations, clinical investigations, and product renewals, as well as providing regulatory input on the development of products and processes internally. This position will report to the RA Manager.

What you’ll do…

  • Provide Regulatory Affairs input into product development projects to ensure all regulatory requirements are met throughout the development process
  • Actively collaborate with Clinical Affairs to develop documentation to be submitted to regulatory authorities and ethics committees for authorization of clinical studies
  • Conduct periodic reporting and other activities required for the continued regulatory compliance of ongoing clinical studies
  • Maintain current knowledge of EU, US, Canadian, and international regulations, guidance, and standards applicable to company products
  • Create and coordinate product technical files, design dossiers, and design history files
  • Interact with regulatory agencies such as the FDA, Health Canada, and EU notified bodies as required for the processing of submissions, regulatory reports, and any other regulatory actions
  • Compile and process materials for license renewals, updates, and registrations
  • Assist with the implementation and maintenance of systems for tracking submissions, and changes thereof, sent to regulators and partners
  • Review marketing material, labeling, and labels for compliance with regulatory requirements
  • Actively participate in evaluation of regulatory compliance of changes to documents, products, processes, and test methods, and define the requirements for regulatory reporting of such changes
  • Conduct post-market surveillance activities, including review of customer complaints, trend analysis, and reporting
  • Ensure continued compliance to applicable privacy regulations for clinical and operational activities
  • Participate in research of regulatory issues and disseminate regulatory information to Production, QA, QC, Engineering teams, and senior management 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 bring to the team these characteristics, plus:

  • Either a bachelor of science or engineering degree
  • A minimum of 3 years of relevant regulatory affairs experience, or equivalent combination of post-graduate education and experience
  • Experience with Class II/III medical devices or combination products
  • In-depth working knowledge of European, US, and Canadian medical device regulatory requirements
  • Knowledge of privacy regulations (e.g., GDPR, PIPEDA, etc.) is an asset
  • Experience with design controls is an asset
  • Excellent written and verbal communication
  • Excellent technical documentation skills
  • Strong organizational and project management skills
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) and Adobe Acrobat

How to apply…

If this position appeals to, apply today by sending your résumé and cover letter to jobs@kardium.com, with the job title “298 Regulatory Affairs Specialist” in the subject line.

To apply for this job email your details to jobs@kardium.com