Join to apply for the Regulatory Affairs Specialist role at Zimmer BiometJoin to apply for the Regulatory Affairs Specialist role at Zimmer BiometAt 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 recognised.What You Can ExpectResponsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process in different regions such as Asia Pacific, Latin America and EMEA.How You'll Create ImpactPreparation, assembly, storage, tracking and retrieval of information pertinent to the regulatory processes, including the regulatory submissions process. May author and publish electronic submissions for product registrations, renewals and registration changes.Maintains registration databases, product registration records, key performance indicators current, and communicates approved registrations.Executes registration processes in assigned countries, working closely with Business Unit Regulatory Teams to request information, business partners "distributors" to ensure registrations are submitted on time and kept current in compliance with applicable legislation.Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new productsEvaluate risk of proposed regulatory strategies; may offer solutionsReviews proposed labeling and package inserts for compliance with applicable regional regulationsRespond to requests for additional information from foreign governmentsReviews proposed product changes for impact on regulatory status of the productSupports the creation of Technical documentation files in the Regulatory Information Management SystemApplies regulations to business practices and provides regulatory input, advice and guidance to cross-functional teamsThis 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 OutStrong writing, communication, and interpersonal skillsStrong attention to detail; ability to multi-task and balance competing prioritiesKnowledge of overall business environment, the orthopedic industry, and the marketplaceAbility to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional areaAbility to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levelsKnowledge of regulations in at least one of the following regions: LATAM, APAC, and EMEA.Ability to identify risk in Regulatory strategiesStrong problem solving skillsEffective negotiating skillsBasic computer skills, including Microsoft Office SuiteYour BackgroundBachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferredEnglish Proficiency is required.A minimum of one year of experience in orthopedic or medical device industry preferredA minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field requiredRegulatory Affairs Certification (US, EU, or Global) preferredA combination of education and experience may be consideredTravel ExpectationsUp to 10%EOE/M/F/Vet/DisabilitySeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionLegalIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at Zimmer Biomet by 2xGet notified about new Regulatory Affairs Specialist jobs in Bogota, D.C., Capital District, Colombia.Bogota, D.C., Capital District, Colombia 2 days agoBogota, D.C., Capital District, Colombia 2 days agoBogota, D.C., Capital District, Colombia 2 weeks agoRegulatory Affairs & Entity Corporate Governance Specialist for US, Canada & CaribbeanBogota, D.C., Capital District, Colombia 1 month agoBogota, D.C., Capital District, Colombia 1 week agoBogota, D.C., Capital District, Colombia 3 weeks agoQuality Assurance and Regulatory Affairs SpecialistBogota, D.C., Capital District, Colombia 2 weeks agoBogota, D.C., Capital District, Colombia 2 weeks agoBogota, D.C., Capital District, Colombia 3 days agoBogota, D.C., Capital District, Colombia 1 day agoBogota, D.C., Capital District, Colombia 2 days agoBogota, D.C., Capital District, Colombia 2 weeks agoBogota, D.C., Capital District, Colombia 1 week agoBogota, D.C., Capital District, Colombia 6 days agoQuality Control Specialist with PortugueseBogota, D.C., Capital District, Colombia 1 week agoQuality Assurance Automation Engineer SpecialistBogota, D.C., Capital District, Colombia 13 hours agoWe're unlocking community knowledge in a new way. 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