🛠 Tech Stack

💼 About This Role

You'll lead regulatory labeling activities for a surgical robotics company, ensuring compliance with global standards. Your core impact will be managing product labeling submissions and cross-functional projects. This role offers broad exposure to medtech compliance and design functions.

🎯 What You'll Do

• Lead regulatory labeling activities for global submissions
• Author user manuals, product inserts, and on-product labels
• Manage external service providers for label artwork design
• Contribute to labeling process improvement initiatives

📋 Requirements

• Bachelor’s degree in scientific or engineering field
• 5+ years experience in medical device regulatory affairs
• Knowledge of 21 CFR 800-1299 and ISO 13485
• Experience with 510(k) submissions and EU MDR

✨ Nice to Have

• Advanced degree in regulatory affairs
• Experience with e-labeling systems
• Proficiency in graphic design software