Senior Quality & Regulatory Affairs Consultant (Medical Devices)

Senior Quality & Regulatory Affairs consultant – Emergo by UL, India (This role is based out of India)

Job responsibilities

+ Provide Quality and/or Regulatory consulting services, independently or with oversight by a Lead QA/RA Consultant or Consultant Manager, which may include but are not limited to:

+ Leverage regulatory affairs experience gained in the medical device industry/medical device consulting area to provide hands-on support to manufacturers with Quality Assurance and Regulatory compliance requests, help resolve client issues, and respond to market-specific inquiries. This role involves regular and frequent interaction with our clients, appropriate communication skills and experience are a must.

+ Prepare/review local or international regulatory submissions e.g., India, South East Asia, EU/USA markets for or on behalf of manufacturers, demonstrate and share knowledge of requirements by market and compile/review technical docume...