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 II collaborates with the Regulatory Affairs, Engineering, and Quality teams to ensure compliance with all regulatory requirements for Paragon 28 products distributed in the United States, Canada, and other territories/regions as assigned. This position is responsible for regulatory strategies, submissions, and communication with government agencies (e.g. FDA, Health Canada), as well as regulatory assessments and reviews of quality management system documents. **How You'll Create Impact** + Review and understand global regulatory requirements (FDA, TGA, EU MDD, EU MDR, Health Canada, etc.) + Maintain compliance to FDA UDI requirements + Assemble and maintain regulatory files (510(k) submissions, STED, Technical Files, etc.) + Assist engineering in implementing verification and validation strategies + Work with regulators to release products into new or established markets + Review and establish predicates for FDA premarket notifications + Review competitive literature to develop regulatory strategies + Support project teams in decisions that affect regulatory compliance + Review marketing literature for regulatory compliance + Registration and listing of devices + Create and maintain product labeling + Knowledge of GMPs + Other duties as assigned **What Makes You Stand Out** A Regulatory Affairs Specialist can stand out by demonstrating a blend of medical device-specific regulatory expertise, technical understanding of orthopedics, and cross-functional collaboration. + Specialized Knowledge in Orthopedic Devices and Software or App Driven Devices + Familiarity with Device Classifications: Knowledge of Class II and III orthopedic devices (e.g., implants, surgical instruments, joint replacements). + Biomechanics & Material Knowledge: Understanding of materials used in implants (titanium, cobalt-chrome, PEEK) and their regulatory implications (e.g., biocompatibility testing, ISO 10993). **Your Background** + Bachelor’s degree in a technical field (Engineering, Biology, or Regulatory Science) and 3-7 years of regulatory experience; or equivalent combination of education and experience. + Knowledge of 21 CFR Part 820, EU MDD 93/42/EEC, EU MDR 2017/745, and ISO 13485 + Understanding of orthopedic and/or implantable devices; previous medical device industry experience required + History of working collaboratively across functions + Excellent attention to detail and proven organizational skills, able to prioritize and multi-task and see projects/assignments to completion + Proficiency in Excel, Word, PowerPoint, Outlook and customer database management systems + Proficiency with FDA’s eSTAR submission tool + Proven leadership and negotiation skills, works well with all levels, able to successfully manage cross-departmental expectations + Excellent written and verbal communication skills **Travel Expectations** 10% of overnight travel is expected EOE/M/F/Vet/Disability