Regulatory Affairs Consultant

Regualtory Affairs Product Manager - PMA Submissions

Overview :

Our client is seeking a Regulatory Affairs Product Manager to support Class III medical device product life-cycle activities at their site outside of Atlanta, Georgia. This role is responsible for ensuring timely delivery of regulatory tasks, maintaining compliance with internal procedures and external regulations, and providing cross-functional support to internal stakeholders.

Key Responsibilities :

• Support preparation and submission of US FDA PMA submissions
• Support maintenance of Canadian product licenses
• Assess product and process changes and perform regulatory impact assessments
• Prepare and maintain PMA-related documentation and other regulatory deliverables
• Provide regulatory support to project core teams, as assigned
• Manage international registrations and renewals, as needed
• Perform regulatory listings for approved products to ensure appropriate shipping controls
• Deliver regulatory support to meet internal customer and business needs, as assigned