Regulatory Affairs Manager (Medical Devices)

Company Description

We are on a relentless mission to eliminate physical disabilities with revolutionary robotics and cutting-edge technology. Our goal is to create a future where advanced machines not only restore abilities but also amplify them, pushing human potential to exciting new heights. Currently, we are developing robotics that merge seamlessly with human movement, empowering individuals to reclaim and redefine their lives. Soon, we will be entering the frontier of neural interfaces, where thoughts translate directly to action, creating a world where the power of the mind knows no limits.

Role Description

This is a full-time on-site role for a Regulatory Affairs Manager, based in Pune. The Regulatory Affairs Manager will be responsible for ensuring regulatory compliance, preparing and submitting regulatory documents, managing regulatory requirements and quality systems, and liaising with relevant regulatory bodies. The role involves overseeing regulatory submissions, maintaining up-to-date knowledge of regulatory changes, and supporting various departments to ensure adherence to regulatory standards.

Qualifications

• Experience in Regulatory Compliance and Regulatory Requirements
• 2+ years of experience
• Knowledge of Regulatory Affairs and Regulatory Submissions
• Proficiency in managing Quality Systems
• Strong analytical and problem-solving skills
• Excellent written and verbal communication skills
• Ability to work collaboratively in a team environment
• Bachelor's degree in Life Sciences, Engineering, or a related field
• Degree /certifications in Regulatory Affairs
• Experience in the medical device industry is a plus