Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist is responsible for obtaining and documenting our mission-critical, Indian regulatory clearances for Masimo’s amazing 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:

What you'll do

• Responsible for obtaining and documenting our mission-critical, Indian regulatory clearances for Masimo’s amazing innovative medical device products
• Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files
• 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

What you need

• 2–5 yrs of experience
• Regulatory affairs
• Import/export
• Any graduate