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 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, and interacting with governmental agencies. An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations and their application is required.

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. Authors and publishes electronic submissionsResearches, analyzes and communicates information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of researchMay assign regulatory affairs (RA) professionals to serve on development project teams as core team members; communicates regulatory strategy for new productsKeeps all areas of Zimmer Biomet informed of regulatory requirements and emerging issues which may affect the registration approval of productsSupports, 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 of the productWrites, manages, and approves the development of package insertsReviews, evaluates, and approves promotion and advertising material for compliance with applicable regulationsInterprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization Assist in the development and influence of regulations and standards where applicableEstablishes Zimmer Biomet RA policies and procedures and ensures compliance with themProvides training and/or guidance to all RA levelsCommunicates with regulatory and governmental agenciesResponsible for oversight and prioritization of departmental tasks and projectsDirects and oversees the work of regulatory professionals, including training and mentoringMiscellaneous responsibilities are assigned

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential 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, and peersStrong interpersonal skills; ability to lead a team and influence othersStrong attention to detailStrong organizational, problem-solving and analytical skillsAdvanced negotiation skills; ability to negotiate with regulatory agencies, management and other groups as necessaryAdvanced knowledge of overall business environment, the orthopaedic industry and the marketplaceMastery of relevant regulations and ability to stay abreast of regulations pertinent to medical devices, biologics, drugs, and combination products as applicableAbility to functional well as a member of the team, team leader, and building relationships between RA and other areas of the organizationAbility to identify and assess business risks to develop regulatory strategyMastery of product knowledge and industry historyMastery anatomic knowledgeAbility to manage projects of various sizes and constitutions; handle increasing levels of responsibility; versatility, flexibility and willingness to work with changing prioritiesStrong computer skillsAdvanced knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EUYour Background Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferredAdvanced degree strong preferred6-8 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EUA minimum of 3 years of experience in orthopaedic or medical device industry preferredRegulatory Affairs Certification (US or EU) preferredA combination of education and experience may be consideredCandidates living within 4-5 hours of Warsaw Indiana are preferredTravel Expectations

Up to 20%

The responsibilities of this role can mainly be performed remotely, with travel to ZB's Warsaw site as needed

EOE/M/F/Vet/Disability