Regulatory Affairs Specialist

Job description

Description JOB SUMMARY: The Regulatory Affairs Specialist (RAS) is responsible for planning and executing global regulatory strategies necessary to obtain and maintain regulatory approvals for new and modified medical devices in International and US regions. The RAS translates regulatory requirements into project/product requirements, assists in preparing regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include preparing International and US regulatory submissions; preparing Technical File, providing documentation for international submissions; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables. ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: - Support the development of regulatory planning and strategies for product submissions in US and International market. - Partner with business unit to provide regulatory support for new products and changes to existing products. Collaborate with other Regulatory Peers and other department cross functional teams to resolve potential regulatory issues and questions from regulatory agenc...