- Location
- Haryana, Gurugram International Techpark, Block I Phase 1 Floor 6, India
- Workplace
- Hybrid
- Type
- Internship
- Seniority
- Internship
- Source
- Workday
Description
Work Flexibility: Hybrid
- Basic understanding of the regulatory requirements under Medical Device Rules, 2017 and the Drugs & Cosmetics Act.
- Assist in preparing and organizing regulatory documentation and submissions for new products and retentions.
- Support RA team in remediation activity for existing submissions / approvals
- Maintain and update regulatory databases, trackers, and filing systems.
- Conduct research on regulatory guidelines and updates issued by authorities.
- Track regulatory timelines and maintain submission status reports.
- Coordinate with internal teams to gather information required for regulatory
- Support the Regulatory Affairs team with administrative and documentation tasks.
- Understand the complaint and adverse event reporting requirements and report such events to the competent authority within the stipulated timelines.
Understand the BIS registration process and requirements
Travel Percentage: 10%