Regulatory Affairs Consultant

# Regulatory Affairs ConsultantMedical Device CompanyMontreal, QC, Canada $110 - $140 per hour CAD Posted 5 days ago## About the RoleGetting a Class III implantable device to market is one of the most complex regulatory challenges in healthcare. It's not just about filling out forms - it's about building a submission strategy that anticipates FDA reviewer questions before they're asked, sequences clinical evidence to tell a compelling story, and keeps Health Canada timelines synchronised so both markets launch within the same quarter. This medical device company needs a regulatory consultant who has been through the full cycle - from pre-submission meetings through 510(k)/PMA clearance to post-market surveillance - and who can bring that pattern recognition to bear on their current product pipeline. You'll work hand-in-glove with R&D, quality, and clinical teams, providing the regulatory intelligence that shapes design decisions long before a submission is filed.## Responsibilities* Pr...