Regulatory Affairs Specialist (Hybrid)

Kardium Inc. • Burnaby, BC

41d • CA$87,000 - CA$91,000 • Hybrid

About The Position

Kardium is seeking a Regulatory Affairs Specialist, Change Control, to join their team. This role is responsible for assessing product, process, design, manufacturing, labeling, and documentation changes for regulatory impact across global markets. The specialist 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. This is a hybrid position located in Burnaby, BC.

Requirements

• 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
• 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

Nice To Haves

• software experience considered an asset
• 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

Responsibilities

• 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

Benefits

• 5% Retirement Savings Plan contribution
• Stock option plan
• Comprehensive medical & dental coverage for all permanent employees – effective as of Day 1, with no waiting period.
• Flexible work environment for daily working hours.
• 3 personal days per year.
• Support for you (and your dependents) overall well-being.
• Top up for maternity leave, adoptive leave, and parental leave for non-birthing parents.
• Benefit coverage for fertility drug treatment.
• Career progression and learning support.
• Professional membership support.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level