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 all facets of regulatory support to market Zimmer Biomet products in APAC region. This includes participating in regional strategy making of regulatory submissions, managing departmental projects, providing guidance and consultation for domestic and international regulations, interacting with governmental and industrial agencies and coordinating with regulatory professionals. How You'll Create Impact Make strategy for regulatory related projects in APAC with APAC country RA leaders and coordinate/support the implementation of project tasks. Manage RA related performance metrics in APAC, e.g. International Registration Request (IRR) for obtaining and maintaining registrations to permit distribution of products in APAC markets and for discontinuation. Monitor Global Trade Services (GTS) system to ensure compliance with product registrations for destination countries that receive Zimmer Biomet products and make sure timely unblock to meet business demand. Serves on development project teams as core team members; communicates regulatory strategy for new products, processes or new software's (such as RIMS), etc. as APAC representative. Assists with the research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products. Establishes Zimmer Biomet RA procedures and ensures compliance with them. Provides training and guidance to associates, interns, specialists, and project managers with regulatory requirements of major markets in APAC. Communicates with Regulatory/Governmental agencies and corporate team as APAC representative. Miscellaneous responsibilities as assigned This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions. What Makes You Stand Out Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports. Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail Ability to manage competing priorities; ability to manage projects of various sizes, constitutions, and management of personnel; versatility, flexibility, and willingness to work with changing priorities. Advanced knowledge of overall business environment, the orthopedic industry and the marketplace; strong product knowledge Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as applicable. Ability to identify and assess business risks to develop Regulatory strategy. Ability to handle increasing levels of responsibility. Ability to lead and influence others. Strong computer skills Ability to negotiate with regulatory agencies, management, and other groups as necessary. Advanced knowledge of medical device related regulations in APAC countries, such as China, Japan, Australia, etc. Your Background Bachelor's degree required; concentration in life sciences, technical/engineering or related field, preferred. Advanced degree strong preferred 5 years of experience in Regulatory Affairs, including preparation of submissions to the APAC/FDA/EU countries A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred. Regulatory Affairs Certification preferred. A combination of education, experience, leadership, strategy and RA influence may be considered Travel Expectations 30% EOE/M/F/Vet/Disability
