ZEISS Group is seeking a Regulatory Affairs Associate in Bengaluru, India, to support regulatory submissions and documentation for global medical device projects. The role involves preparing and updating regulatory documents, executing country-specific submissions, and coordinating with various teams to ensure compliance and timely deliverables
Job Summary
To support execution of regulatory submissions, documentation, and country communications for global medical device projects under guidance of the RA Project Manager, ensuring compliance with applicable regulations and timely deliverables.
Prepare and update regulatory documents including: STED sections GSPR checklists DoC drafts Change notifications and CIA documentation.
Execute country-specific submissions and notifications. Track registration status and authority timelines. Maintain MRA records and release documentation in SAP/eDMS.
Matching Summary
Match Score: 85
ZEISS Group is seeking a Regulatory Affairs Associate in Bengaluru, India, to support regulatory submissions and documentation for global medical device projects. The role involves preparing and updating regulatory documents, executing country-specific submissions, and coordinating with various teams to ensure compliance and timely deliverables.
Skills & Requirements
Must-have
Regulatory submissions and documentation
Country-specific submissions and notifications
Prepare and update regulatory documents
Maintain regulatory trackers and dashboards
Cross-functional coordination with QA, Clinical Affairs