**Requisition Number**: AMER28216 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: Responsible 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 **Principal Duties and Responsibilities**: -Preparation, 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 products - Evaluate risk of proposed regulatory strategies; may offer solutions - Reviews proposed labeling and package inserts for compliance with applicable regional regulations - Respond to requests for additional information from foreign governments - Reviews proposed product changes for impact on regulatory status of the product - Supports the creation of Technical documentation files in the Regulatory Information Management System - Applies regulations to business practices and provides regulatory input, advice and guidance to cross-functional teams **Expected Areas of Competence**: -Strong writing, communication, and interpersonal skills - Strong attention to detail; ability to multi-task and balance competing priorities - Knowledge of overall business environment, the orthopaedic industry, and the marketplace - Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area - Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels - Knowledge of regulations in at least one of the following regions: LATAM, APAC, and EMEA. - Ability to identify risk in Regulatory strategies - Strong problem solving skills - Effective negotiating skills - Basic computer skills, including Microsoft Office Suite **Education/Experience Requirements**: -Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred - English Proficiency is required. - A minimum of one year of experience in orthopedic or medical device industry preferred - A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required - Regulatory Affairs Certification (US, EU, or Global) preferred - A combination of education and experience may be considered **Travel Requirements**: 10%