Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions
Responds to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to affiliates
Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research
Assigns Regulatory Affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new products
Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products
Supports, supervises, and participates (as necessary) in the development of package inserts, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews of proposed product changes for impact on regulatory status
Writes, manages, and approves the development of package inserts
Reviews, evaluates, and approves promotion and advertising material for compliance with applicable regulations
Interprets and applies FDA regulations to business practices and provides regulatory input, advise, and guidance to the organization
Establishes Zimmer Biomet RA policies and procedures and ensures compliance with them
Provides training and guidance to entry-level associates, interns, specialists, and project managers
Communicates with Regulatory/Governmental agencies
Responsibility for oversight and prioritization of departmental tasks and projects
Directs and oversees the work of regulatory professionals, including training, mentoring and ensuring professional development
Miscellaneous responsibilities as assigned
