Principal Regulatory Affairs Specialist

Job Summary

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