Regulatory Affairs Manager

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised. **What You Can Expect** ----------------------- Responsible for managing support of regulatory affairs systems used to support the Zimmer Biomet RA teams. This includes understanding the develop regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, interacting with governmental agencies and managing a staff of regulatory professionals. **How You'll Create Impact** ---------------------------- 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