Regulatory Affairs Specialist

Overview

The Regulatory Affairs Specialist obtains and documents Indian regulatory clearances for Masimo's medical device products, serving as the sole RA representative on project teams for new products or product changes.

What you'll do

• Support the APAC regulatory team with 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 on filings and responses to health authority inquiries.
• Assist in maintaining product listings and establishment registrations with India regulatory authorities.

What you'll need

• A minimum of 2 years of work experience in a medical device Class II/III environment.
• Local Indian regulatory experience in the medical device industry.
• Working knowledge of IT equipment import/export rules and the BIS certification 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.

Details

• Location: Bengaluru, India.
• Eligible for a remote work arrangement in which the role can be performed from home; further details provided by the interview team.