Regulatory Affairs Specialist
BengaluruFull-time2–5 yrsPosted 3 months ago
Mid-level pharma role at Masimo in Bengaluru. Needs 2+ years and a B.Tech or B.E..
About the role
Regulatory Affairs Specialist at Masimo. Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files.
What you'll do
- 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
- Familiar with BIS requirements and supporting import/exports for medical devices
What you need
- Regulatory affairs
- Documentation
- Import/export
- Sales
- SOP writing
- Communication