REGULATORY AFFAIRS SPECIALIST

40.000.000 - 80.000.000


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. We focus on development opportunities, employee resource groups (ERGs), flexible working, competitive rewards, wellness incentives, and a culture of recognition and performance awards. We are dedicated to creating an inclusive environment where every team member feels respected, empowered, and recognized. What You Can Expect Responsible for assisting the team with regulatory filings necessary to market Zimmer Biomet products. This role requires an intermediate understanding of medical devices, their use, and the regulatory submission process in North America. How You'll Create Impact Prepare, assemble, store, track, and retrieve information related to regulatory processes, including electronic submissions for product registrations, renewals, and changes. Maintain registration databases, product registration records, and communicate current registrations. Execute registration processes in assigned countries, collaborating with Regulatory Teams and business partners to ensure timely and compliant submissions. Provide regulatory guidance to development teams; develop regulatory strategies for new products. Evaluate regulatory risks and propose solutions. Review labeling and packaging for compliance. Support post-market activities such as handling product complaints, field actions, and recalls. Review promotional materials for regulatory compliance. Assess the regulatory impact of proposed product changes. Communicate with regulatory agencies under supervision. Apply regulations to business practices and advise cross-functional teams. What Makes You Stand Out Strong communication, writing, and interpersonal skills. Attention to detail and ability to manage multiple priorities. Knowledge of the orthopaedic industry and marketplace. Ability to stay updated on regulations for medical devices and related products. Effective relationship-building and communication skills across organizational levels. Knowledge of North American and Latin American regulations, including US and EU. Ability to identify regulatory risks. Problem-solving and negotiation skills. Proficiency in Microsoft Office. Your Background Proficiency in English (B2+ or C1). Bachelor’s degree in life sciences, engineering, or related field preferred. 1+ year of experience in orthopaedics or medical devices preferred. 3-5 years in Regulatory Affairs, Engineering, or Quality required. Regulatory Affairs Certification preferred. Please ensure your resume is in English when applying, as applications in other languages cannot be considered. Travel Expectations Travel may be required based on business needs. EOE/M/F/Vet/Disability #J-18808-Ljbffr

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