Principal Regulatory Affairs Specialist

Serving as the regulatory affairs lead on cross-functional teams, the full-time Principal Regulatory Affairs Specialist will manage product line regulatory submissions and registrations for the Dental Solutions business across global markets while working remotely in the United States. Key responsibilities Drive regulatory strategy and execution for high-volume markets, including the United States, Canada, and the European Union Conduct global regulatory change assessments and coordinate activities for assigned drug and medical device products Provide regulatory review and input on technical documentation and support for labeling and registration updates Required qualifications Bachelor's Degree or higher and seven years of regulatory affairs experience in the drug and/or medical device industry Experience authoring regulatory submissions and technical documentation for drug and medical device products in the United States, Canada, and the European Union Experience with NDA and OTC monograph drugs and medical devices Experience revising and approving product labeling to ensure compliance with global regulatory requirements Experience authoring regulatory strategies and regulatory change assessments