Regulatory Affairs Consultant

Regualtory Affairs Product Manager - PMA SubmissionsAre you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.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 submissionsSupport maintenance of Canadian product licensesAssess product and process changes and perform regulatory impact assessmentsPrepare and maintain PMA-related documentation and other regulatory deliverablesProvide regulatory support to project core teams, as assignedManage international registrations and renewals, as neededPerform regulatory listings for approved products to ensure appropriate shipping controlsDeliver regulatory support to meet internal customer and business needs, as assigned

Created: 2025-10-09