ALKU
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. 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 Seniority level
Mid-Senior level Employment type
Contract Job function
Consulting Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr
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. 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 Seniority level
Mid-Senior level Employment type
Contract Job function
Consulting Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr