Regulatory Affairs Specialist - Costa Rica & Central America Region

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 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.

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.

Please refer the Job description for details