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** The Regulatory Affairs Specialist ensures the company is compliant with all applicable regulations and standards, executes and keeps track the global registration plan for the medical devices within the product life cycle. Responsible for assisting the team with regulatory filings, executing and assuring the process end to end as necessary to market Zimmer Biomet products in the region and scope assigned. Regulatory Affairs Specialist is responsible for managing internal regulatory processes in order to ensure compliance with all regulations and thus, obtain government approval to market Zimmer Biomet products in the region of competence. **How You'll Create Impact** • Responsible of obtaining sanitary registration for the product portfolio by the assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions. • Managing day to day monitoring of the company regulatory activities pertinent to the scope assigned, and provide on time resolution to requests from government authorities and/or distributors, in order to facilitate the business continuity. • Assist with the research, analysis, communication and reports of information pertaining to the appropriate regulatory pathway for new or modified products, in order to…. obtain sanitary registrations on a timely manner. • Provides regulatory assessments and involves other team members and areas, to develop regulatory strategy for new products given local requirements, ensuring accurate and timely submissions to regulatory agencies. • Evaluate risk of proposed regulatory strategies, based on his/her local or regional experience, presenting and offering solutions and new alternatives to implement those strategies. • Reviews proposed product changes for impact on regulatory status of the product. • Communicates with regulatory and governmental agencies with supervision. This job description indicates the general nature and level of the position. The responsibilities described are illustrative but not limiting. **What Makes You Stand Out** Degree of Schooling: + University Bachelor’s degree (or non-US equivalent) required; focused in life sciences, technical/engineering or related field. Competencies/Skills: + Strong writing, communication, and interpersonal skills + Strong attention to detail; ability to multi-task and balance competing priorities. + Knowledge of overall business environment, the orthopedic 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 FDA, EU, and other regulatory body regulations for **Costa Rica, El Salvador, Panama, Honduras and Guatemala.** + Strong problem-solving skills. + Effective negotiating skills + Required English Language Level: Intermediate + ERP and level of knowledge: Intermediate (RIMS, Windchill, GTS) + Specialization Courses (if applicable): Basic computer skills, including Microsoft Office Suite **Your Background** + **English proficiency:** B2 level required. + **Experience:** Minimum of 3 years in similar positions (3-4 years preferred). + **Areas of expertise:** Regulatory Affairs, Quality (specifically in submissions), or related fields. + **Industry experience:** At least 1 year in the orthopedic or medical device industry preferred. + **Regulatory experience:** Must have experience working with regulatory entities in **Costa Rica** and **Central America** (El Salvador, Panama, Honduras, Guatemala) or, alternatively, regional experience covering multiple LATAM countries. **Travel Expectations** EOE/M/F/Vet/Disability