Warsaw, Indiana

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.

Responsible for managing all facets of regulatory support to market Zimmer Biomet products. This includes developing 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.

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 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

Expected Areas of Competence

• 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 orthopaedic 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 function well as a member of the team and team leader, as well as build relationships between RA and other areas of the organization • Ability to identify and asses business risks to develop Regulatory strategy • Mastery anatomic knowledge • Ability to handle increasing levels of responsibility • Ability to build and lead a strong RA team; ability to lead and influence others • Strong computer skills • Ability to negotiate with regulatory agencies, management, and other groups as necessary Advanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU as applicable

Education/Experience Requirements

• Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred • Advanced degree strong preferred • 6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU • A minimum of 3 years of experience in medical device, drugs, biologics, and/or combination products, preferred • Regulatory Affairs Certification (US or EU) preferred A combination of education, experience, leadership, strategy and RA influence may be considered

Travel Requirements

Up to 20%

Additional Information

EOE/M/W/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.

Warsaw, Indiana

Zimmer Biomet Team Members share the singular purpose of working to restore mobility and improve the quality of life for patients around the world. With operations around the world, we’re looking for Team Members who would like to make a difference in people’s lives.

We hire talented and highly motivated people with a range of skills, experiences, and backgrounds to fulfill roles in careers such as engineers and clinicians, or in quality and regulatory affairs, manufacturing, marketing, sales, and information technology, to name just a few.

Your chance to push the boundaries of innovation and make a valued contribution to helping people around the world find renewed vitality starts here. If you’d like to learn more about becoming a Zimmer Biomet Team Member, here are some Frequently Asked Questions.

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Recruitment Fraud Alert

Zimmer Biomet is an equal opportunity and affirmative action employer. M/F/Disability/Veteran

Applicants have rights under Federal Employment Laws:  Family and Medical Leave Act (FMLA) PosterEqual Employment Opportunity (EEO) PosterSupplemental Equal Employment Opportunity (EEO) is the Law PosterEmployee Polygraph Protection Act (EPPA) PosterPay Transparency Notice Poster

U.S. Federal law requires all employers to verify the identity and employment eligibility of all persons hired to work in the United States. Zimmer Biomet participates in E-Verify to confirm work authorization. View the E-Verify posters in English or Spanish, as well as the Right to Work poster in English or Spanish.

We invite all interested and qualified candidates to apply for employment opportunities.

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