Regulatory Affairs Specialist (Hybrid)

Job description

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 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. Please note, this opportunity is a hybrid work arrangement, located in Burnaby, BC. What you’ll be doing Your responsibilities will include: • 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 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: Experience and Qualifications: • 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 Skills and Attributes: • 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 • Strong organizational, analytical, and problem-solving skills with high attention to detail • 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 • A sense of urgency, agility, transparency, respect, and collaboration in a team setting Compensation Kardium has listed the total cash compensation range (base salary + 5% Retirement Savings Plan contribution) that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted. As a permanent employee, you will also participate in Kardium’s stock option plan. • $ 87,000 – 91,000 (CAD Annually) Your Benefits & Well-being The total cash we’ve listed for this position includes a base salary, plus an annual contribution to a Retirement Savings Plan account to help support your financial goals. Comprehensive medical & dental coverage for all permanent employees – effective as of Day 1, with no waiting period. Work-day flexibility – we offer a flexible work environment for daily working hours. In addition, we provide 3 personal days per year. Support for you (and your dependents) overall well-being. Family building – we provide top up for maternity leave, adoptive leave, and parental leave for non-birthing parents. Employees can also enroll in benefit coverage for fertility drug treatment. Career progression and learning support. Professional membership support. Life at Kardium What makes us a great place to work? 1. Our Purpose 2. Our People 3. 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 ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, Irish ERG, Brazilian ERG, and Early Career at Kardium 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!