Regulatory Affairs Specialist (Hybrid)
$87,000–$91,000 year
HybridBurnaby, British Columbia, Canada
Job Summary
Assess product, process, design, manufacturing, labeling, and documentation changes for regulatory impact across global markets. 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.
Required Qualifications
- Bachelor's degree in Engineering, Science, or a related technical discipline
- 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
- Demonstrated experience assessing regulatory impact of product, process, manufacturing, labeling, supplier, or documentation changes
Desired Qualifications
- mechanical or electrical engineering background
- knowledge of post-market change requirements
- Experience with software-related device changes, software lifecycle documentation, or software validation
- 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
- hybrid work arrangement
- located in Burnaby, BC
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