Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world. This position is responsible for oversight of the development of regulatory submissions; departmental projects; provision of guidance and consultation for domestic and international regulations; interaction with governmental agencies and overseeing/managing a staff of regulatory professionals. The Director formulates strategic plans and develops departmental budgets. The Director is also responsible for providing Regulatory guidance to the company, including Zimmer Biomet executive management and the Legal department, and must be aware of current developments and potential changes and opportunities in global regulatory jurisdictions.

Principal Duties and Responsibilities

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. Assists with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research. Oversight of all regulatory functions, including regulatory submissions and development of dossiers for global registration Develops and communicates regulatory strategy and manages staff to achieve key objectives; is alert to the potential to use new technology to achieve greater efficiencies. Assigns RA professionals to serve on development project teams as core team members. Manages and develops regulatory professionals to lead them to higher performance levels and maximize their career potential. Provides training and guidance to all levels of professionals. Interprets and applies global regulations to business practices and provides regulatory input, advice and guidance to the organization. Assumes a leadership role among RA department, identifying best practices and provides regulatory input, advice and guidance to the organization. Responsibility for oversight and prioritization of departmental tasks and projects. Establishes and approves RA policy and procedures and ensures compliance with them. Develops the departmental budget and manages finances to achieve key objectives and optimize departmental function. Keeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of products. Communicates with regulatory and governmental agencies. Miscellaneous responsibilities as assigned.

Expected Areas of Competence

§ Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including Regulatory agencies, superiors, peers, and direct reports. § Strong attention to details, and ability to multitask. § Ability to manage projects of various sizes, constitutions, and management of personnel. § Mastery of relevant Regulations, and ability stay abreast of regulations pertinent to medical devices, biologics, drugs, combination products and IVDs as applicable. § Mastery of product knowledge and industry history § Mastery anatomic knowledge § Able to identify and assess business risks and develop Regulatory strategy. § Ability to negotiate with Regulatory agencies, management, and other groups as necessary. Ability to building relationships between RA and other parts of the organization. § Ability to lead a team, influence others and, through strong organizational skills, handle increasing levels of responsibilities. § Management and direct supervision of personnel. Ability to make independent decisions on resources and performance. § Strong tactical and strategic thinking skills and administrative and leadership ability. § Advanced knowledge of overall business environment, the orthopaedic industry, and the marketplace § Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside the US/EU.

Education/Experience Requirements

§ Bachelor’s Degree (or non-US equivalent) required. Degree or background in life sciences, technical (engineering) or related field preferred § Advanced degree strongly preferred § Regulatory Affairs Certification (U.S. or EU) preferred § A minimum of 10 years prior RA experience. o The incumbent’s regulatory background should include the medical device area, and preferably should include orthopaedic experience. o Experience in the areas of drug, biologics, and combination products regulations is also desirable. § A minimum of five years of experience managing direct reports · A combination of education and experience may be considered

Travel Requirements

Up to 25%

Additional Information

EOE M/F/Vet/Disability At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated. Compensation range: $195,000 - $243,000