Senior Regulatory Affairs Manager

Job Summary

A company is looking for a Sr Manager Regulatory Affairs.

Key Responsibilities

• Oversee the day-to-day functions of the Regulatory Affairs team in India
• Contribute to and execute regulatory strategies for medical and non-medical devices
• Lead regulatory submissions and provide guidance on compliance with global regulations

Required Qualifications

• Bachelor's degree in a relevant field or equivalent experience
• 8 - 10 years of experience in a regulated industry, preferably FDA and Software as a Medical Device
• Strong knowledge of FDA Quality System Regulations, including 21 CFR 11 and 21 CFR 820
• Experience with regulatory filings for US FDA Class I and II medical devices
• Knowledge of Medical Devices Regulations and relevant ISO standards