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 talented 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 inspired, invested, cared for, valued, and have a strong sense of belonging. **What You Can Expect** Responsible for managing all facets of regulatory and quality function, to market Zimmer Biomet products in Brazil. This includes developing regulatory submissions, managing departmental projects, creating and reviewing labeling, providing guidance and consultation for domestic and international regulations, leading the local quality management system of a distribution site, interacting with governmental agencies, and managing a staff of regulatory and quality 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 + Serves as RAQA leader, interacting and collaborating with local General Manager and cross-functional leaders + 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 + Keeps all areas of Zimmer Biomet informed of RAQA requirements and emerging issues which may affect the registration approval of products and local QMS, anticipating obstacles and implementing proactive action plans + Supervises, local labeling requirements, evaluation of promotion and advertising material for compliance with applicable regulations, and reviews proposed product changes for impact on regulatory status + Establishes Zimmer Biomet RAQA policies and procedures and ensures compliance with regional QMS + Communicates with Regulatory/Governmental agencies and industry associations + Responsibility for oversight and prioritization of departmental tasks and projects + Directs and oversees the work of regulatory and quality professionals, including training, mentoring, and ensuring professional development + Ensures compliance with local and corporate QMS requirements for distribution sites, maintains FDA Device Foreign Establishment Registration, conducts monthly functional alignment meetings and QARA management reviews twice a year, maintains audit schedule of local authorized distributors, supports internal and external audits, ensures effective QMS sub-systems performance, and promotes best RAQA practices + Other responsibilities as assigned _This is not an exhaustive list of duties or functions and might not nece_ _s_ _sarily comprise all of the e_ _s_ _sential functions for purposes of the Americans with Disabilities Act._ **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; versatility, flexibility, and willingness to work with changing priorities + Advanced knowledge of overall business environment, the orthopedic industry and the marketplace; + Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, biologics and combination products as applicable + Ability to function well as a member of the team and team leader, as well as build relationships between RAQA and other areas of the organization + Ability to identify and asses business risks to develop Regulatory strategy + Ability to build and lead a strong RA team; ability to lead and influence others + Strong systems and Microsoft Office knowledge + Advanced knowledge of specific country health regulations(including labeling regulations) and regulations outside of the US/EU as applicable + Quality Assurance knowledge is preferred **Your Background** + Bachelor´s degree required; concentration in life sciences or related field, preferred + Advanced English level is required + Solid experience in Regulatory Affairs, including preparation of submissions to Govermental Agencies, quality, and QMS requirements + Experience in medical device industry, biologics, and/or combination products is preferred **Travel Expectations** Up to 20% EOE/M/F/Vet/Disability