RAQA Specialist
Core
Regulatory Affairs Specialist responsible for creating medical device technical documentation, evaluating device changes, executing registration strategies, and ensuring marketing material compliance for the India market.
Role type
Senior Regulatory Affairs Specialist (Medical Devices)
Builds
Medical device registration dossiers and compliant marketing materials for the Indian market
Domain
Medical Devices / Regulatory Affairs / India
Deliverable
client delivery
Required skills
India Medical Device Rules knowledge, Medical device registration dossier preparation, Regulatory impact assessment, Marketing material compliance review, Quality Management System (QMS) support, Stakeholder coordination, Technical documentation translation
Preferred skills
US FDA 21 CFR knowledge, ISO13485 working knowledge, ASEAN country registration experience
Technologies
Microsoft Word, Excel, PowerPoint, Outlook
Responsibilities
Prepare and submit medical device technical documentation per India rules; Assess regulatory impact on new devices or product changes; Coordinate registration strategy with sales/marketing; Reply to regulatory inquiries; Review marketing materials for compliance; Support QMS activities like CAPA and audits
Seniority
Senior, hands-on IC