Regulatory Affairs Specialist

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. 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 obtained FDA approval and officially begun the commercial launch of the Globe® Pulsed Field System. This is a pivotal and exciting time in our journey, as we bring this life-changing technology to patients As a Regulatory Affairs Specialist, Change Control, you will be responsible for assessing product, process, design, manufacturing, labeling, and documentation changes for regulatory impact across global markets. You will partner closely with Engineering, Quality, Manufacturing, Product Development, Clinical, and Commercial teams to evaluate proposed changes, ensure they are scientifically justified, clearly documented, and determine the appropriate regulatory reporting pathway. This role is well suited to a candidate with a strong technical foundation, ideally in mechanical or electrical engineering, with software experience considered an asset. Represent Regulatory Affairs in the change control process and provide regulatory assessments for proposed changes to products, processes, test methods, manufacturing sites, suppliers, labeling, and technical documentation Determine whether changes require regulatory notification, submission, approval, technical documentation updates, or other market-specific actions before implementation Collaborate with Engineering, Quality, Manufacturing, Supply Chain, Clinical, and Commercial stakeholders to define regulatory requirements, and implementation constraints Review design change documentation, risk assessments, verification and validation documentation, labeling updates, and manufacturing change records to ensure regulatory impact is appropriately addressed Support maintenance of global regulatory registrations, licenses, technical documentation, and submission history affected by approved changes Prepare or support regulatory submissions, notifications, annual updates, and technical documentation updates required as a result of product or process changes Maintain clear, audit-ready regulatory rationales and records within the change control system and associated regulatory files Monitor applicable EU, FDA, Health Canada, and international regulatory requirements, guidance, and standards related to device changes and lifecycle management Contribute to continuous improvement of regulatory change control procedures, templates, decision trees, and cross-functional training materials Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. You will be successful in this role because you possess these attributes: Bachelor’s degree in Engineering, Science, or a related technical discipline; mechanical or electrical engineering background is preferred Prior experience in Regulatory Affairs, Quality, or Engineering in a regulated medical device environment Experience reviewing engineering documentation, design changes, risk management files, verification and validation evidence, and technical documentation Working knowledge of EU, FDA, Health Canada, and international medical device regulatory requirements, with knowledge of post-market change requirements considered an asset. Demonstrated experience assessing regulatory impact of product, process, manufacturing, labeling, supplier, or documentation changes is an asset Experience with software-related device changes, software lifecycle documentation, or software validation is an asset Strong technical judgment and ability to interpret engineering changes in a regulatory context Excellent written and verbal communication skills, with the ability to document clear regulatory rationales and influence cross-functional decisions Ability to manage multiple change assessments, priorities, and implementation timelines in a fast-paced environment Collaborative working style with the ability to partner effectively with Engineering, Quality, Manufacturing, Regulatory, and Commercial stakeholders Comfort working within electronic quality management systems, regulatory databases, and document control systems Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint and Outlook) and Adobe Acrobat Kardium has listed the total cash compensation range (base salary + 5% Retirement Savings Plan contribution) that we expect to pay applicants