Senior Regulatory Affairs Specialist
Core
Senior Regulatory Affairs Specialist managing product registrations, licenses, and compliance for medical devices in India.
Role type
Senior IC Regulatory Affairs Specialist
Builds
Regulatory submissions and product registrations for Medtronic's medical device portfolio in India
Domain
Healthcare / Medical Devices / Indian Regulatory Landscape
Required skills
Regulatory strategy development, product lifecycle management, stakeholder coordination, submission timeline management, compliance monitoring, documentation preparation, regulatory authority interface
Preferred skills
M.Pharm degree, multinational organization experience, multi-therapy area support, complex regulatory challenge resolution, clinical trial regulatory exposure
Technologies
CDSCO, State FDA, BIS, DoT, Customs systems
Responsibilities
Manage product registrations, import licenses, renewals, and post-approval change submissions; Develop and execute regulatory strategies for new product introductions; Interface with regulatory authorities (CDSCO, State FDA, BIS, DoT, Customs); Prepare and submit regulatory documentation; Partner with Sales, Marketing, Supply Chain, and Global Regulatory teams; Monitor submission timelines and approval status; Provide regulatory guidance on compliance and product changes; Maintain accurate regulatory records and support responses to queries and inspections