Regulatory Affairs Program Manager

Job Title Regulatory Affairs Program Manager The Regulatory Affairs Program Manager will be responsible for Providing Regulatory Technical Competency tactical and strategic to the AM D business group including providing accurate and consistent regulatory recommendations decisions and feedback to product development and manufacturing teams and preparing comprehensive regulatory strategies for new devices and significant post market changes Assess product changes for impact on global regulatory registrations ensuring continued compliance with applicable regulations Create detailed written regulatory plans that can be used to support international regulatory submissions and global product sales Develop and prepare product registration submissions for the US Canada EU and support submission preparation for additional regulated markets Review and approve advertising promotional items and labeling for regulatory compliance Perform regulatory impact and regulatory complianc...