Regulatory Affairs Specialist
Core
Obtain and document mission-critical Indian regulatory clearances for medical device products and manage international/domestic filings for the APAC region.
Role type
Regulatory Affairs Specialist (Medical Devices)
Builds
Regulatory submissions, technical files, and establishment registrations for medical devices in India and APAC.
Domain
Life Sciences / Medical Devices / Regulatory Affairs
Required skills
Indian regulatory affairs, medical device Class II/III compliance, IT equipment import/export rules, BIS certification processes, technical file compilation, audit response management.
Preferred skills
Patient monitor systems experience, ISO 13485 Quality Systems knowledge, Class II medical device submission requirements.
Responsibilities
Manage international and domestic filings/registrations, draft and compile technical files, submit tender requests, respond to audit findings, communicate with headquarters on local regulation changes, maintain product listings and establishment registrations with India authorities.
Seniority
Mid-level, hands-on IC