Regulatory Affairs Specialist – (EU MDR) (Montreal)

Join Amaris Consulting as a Regulatory Affairs Specialist embedded within a dynamic Trauma/CMF/Biomaterials team at one of our industry-leading teams in the medical device sector. You will support regulatory planning for new product introductions and product changes, while contributing to the maintenance of global regulatory compliance.

Your responsibilities

• Support global regulatory affairs activities, including regulatory input to new product development and sustaining engineering teams
• Prepare and submit regulatory documentation for product registration and licensing across key markets: US, EU, Japan, China, and others
• Act as liaison between project teams and global health authorities, managing Q&A flows and consolidating registration deliverables
• Obtain export/import documentation (FDA Certificates of Export, Certificates of Analysis, Apostille) as required
• Maintain regulatory tracking databases to ensure accurate and t...