[Hiring] Regulatory Affairs Specialist @Danaher Corporation

Role Description

The Regulatory Affairs Specialist is responsible for obtaining and documenting our mission-critical, Indian regulatory clearances for Masimo’s innovative medical device products. The individual will be the sole RA representative on various project teams for new products or product changes.

In this role, you will have the opportunity to:

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

Qualifications

• 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 are required.
• Working knowledge of IT equipment import/export rule and BIS certs application process.

Requirements

• Ability to travel as needed.

Benefits

• Comprehensive, competitive benefit programs that add value to our lives.
• Flexible, remote working arrangements for eligible roles.
• Enriching careers, no matter the work arrangement.