Regulatory Affairs Lead
VB Spine · Burlington, Ontario, CA
Regulatory Affairs Lead Location: Burlington, ON, Canada Company: VB Spine Looking for a career where your work truly matters? At VB Spine, you’ll be part of...
Job description
Regulatory Affairs Lead Location: Burlington, ON, Canada Company: VB Spine: Looking for a career where your work truly matters? At VB Spine, you’ll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. We’re the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Specialist, Regulatory Affairs in our Regulatory Affairs function supporting the Spine division in Canada, you’ll play a key individual contributor role in preparing and coordinating regulatory submissions, ensuring compliance with local and regional requirements, and supporting the successful registration and maintenance of medical devices across the Canadian market. What You’ll Do: - Coordinate and prepare document packages for regulatory submissions for new and mature products to ensure alignment with Canadian and regional registration requirements - Compile all materials required for submissions, license renewals, and annual registrations - Recommend changes to labeling, manufacturing, marketing materials, and c...