JOB DESCRIPTION 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 recognized.What You Can ExpectResponsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This is an entry level position, providing training towards full competency in Regulatory Affairs (RA). This position requires a basic understanding of medical devices and their use as well as a basic understanding of the regulatory submissions process in Colombia and Latin America. May perform some or all of the following functions, depending on specific assigned focus.How You'll Create ImpactCoordinate and assist in the preparation of technical documentation for use in regulatory submissions for product registrations, renewals and registration changesAssist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified productsMay aid in regulatory direction to development project teams as a core team member; supports regulatory strategy for new productsReviews proposed labeling and package inserts for compliance with applicable international and country regulationsMaintains registration databases, product registration records, key performance indicators current, and communicates approved registrations.Assist in the review and evaluation of promotion and advertising material for compliance with applicable regulationsSupports and reviews proposed product changes for impact on regulatory status of the productFollows Zimmer Biomet RA policies and proceduresMiscellaneous responsibilities as assignedWhat Makes You Stand OutStrong writing, communication, and interpersonal skillsStrong attention to detailStrong problem-solving and analytical skillsAbility to work with rapid changes; flexible and able to balance competing prioritiesAbility to learn and apply regulations pertinent to medical devices, biologics, drugs and combination products, specific to the product registration process in Latin AmericaSelf-motivated and capable to work in a diverse, fast-paced and dynamic environmentAbility to build strong relationships; communicate effectively at all levelsBasic computer skills, including Microsoft Office SuiteYour BackgroundBachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field preferredIntermediate English Proficiency is required, Portuguese is preferred.Limited regulatory submission preparation experience a plusTravel ExpectationsUp to 10%EOE/M/F/Vet/Disability
