Montreal Regulatory Affairs Consultant Role

Join a leading medical device company in Montreal as a Regulatory Affairs Consultant focusing on complex Class III submissions. Leverage your expertise to navigate FDA and Health Canada pathways effectively.
In this pivotal role, you'll draw on over seven years of regulatory affairs experience to prepare, file, and manage submissions for 510(k), PMA, and license applications. Your contributions will influence the submission strategy, ensuring alignment between R&D and clinical teams while maintaining compliance across multiple markets. You'll be the main contact for reviewers and keep all registrations and listings up to date.
Key Responsibilities:
• Prepare FDA 510(k) and PMA submissions for clearance
• Craft regulatory strategies for product launches and changes
• Serve as primary contact with FDA and Health Canada reviewers
• Maintain product registrations including renewal deadlines
• Support facility inspections and prepare necessary documentation
Requireme...