Regulatory Affairs Specialist

About This Role

This role involves obtaining and documenting Indian regulatory clearances for innovative medical device products. The specialist will serve as the sole Regulatory Affairs representative on various project teams for new products and product changes.

Responsibilities

• Support the APAC regulatory team in managing international and domestic filings and registrations, including drafting and compiling technical files, tender request submission, and audit finding responses
• Communicate with the headquarter regulatory team on local regulation changes with impact assessment
• Assist in communications with global regulatory representatives to help with filings and responses to inquiries from health authorities
• Assist in maintaining product listings and establishment registrations with Indian regulatory authorities

Requirements

• A minimum of 2 years of work experience in a medical device Class II/III environment
• Local Indian Regulatory experiences in the medical device industry
• Working knowledge of IT equipment import/export rules and BIS certs application process
• Ability to travel as needed

Nice to have:

• Experience in patient monitor systems, hospital-based products, software, or electronic device products
• Knowledge of regulatory submission requirements for India Class II medical devices
• Experience in Quality Systems per ISO 13485

Benefits

• Comprehensive, competitive benefit programs
• Health care program
• Paid time off

About the Company

Masimo, a Danaher operating company, is a global medical technology company that develops and produces industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Its mission is to empower clinicians to transform patient care through innovation.