Join to apply for the Regulatory Affairs Specialist, LATAM role at Zimmer Biomet 2 weeks ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Specialist, LATAM role at Zimmer Biomet 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 recognised. What You Can Expect 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 the Latin America region. How You'll Create Impact 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 Post-market Surveillance: Supports processing of product complaints, field actions and product recalls Reviews and evaluates promotional and advertising material for compliance with applicable regulations and procedures Reviews proposed product changes for impact on regulatory status of the product Communicates with regulatory and governmental agencies with supervision Applies regulations to business practices and provides regulatory input, advice and guidance to cross-functional teams What Makes You Stand Out 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 Latin America regulatory body regulations and other regions such as US and EU Ability to identify risk in Regulatory strategies Strong problem solving skills Effective negotiating skills Basic computer skills, including Microsoft Office Suite Your Background Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred English Proficiency is required, Portuguese is preferred. A minimum of one year of experience in orthopaedic 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 Expectations EOE/M/F/Vet/Disability 5362 Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Legal Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Zimmer Biomet by 2x Get notified about new Regulatory Affairs Specialist jobs in Bogota, D.C., Capital District, Colombia . 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