Regulatory Affairs Specialist
About the role
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. As a key member of the Enabling Tech team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. We are looking for an experienced Regulatory Affairs Specialist to join our global Regulatory Affairs team. In this role, you will develop and execute regulatory strategies for innovative medical devices, software, and AI-enabled technologies, helping bring them to market across the US, Europe, and Australia. The position is primarily office‑based with occasional travel to manufacturing and clinical sites and surgeon workshops, offering hands‑on exposure to surgical instruments, navigation systems, and innovative medical technologies. Travel is required up to 10% of the time.
Responsibilities
- Develop and execute regulatory strategies for new and existing medical devices and software.
- Lead and support regulatory submissions, including FDA 510(k), EU MDR technical documentation, and TGA submissions.
- Work closely with Engineering, Clinical, Quality, and Product Development teams throughout the product lifecycle.
- Provide regulatory guidance on product development, risk management, clinical evidence, testing, labeling, and product changes.
- Interact with FDA, Notified Bodies, and TGA and support