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Gurugram, HR 122001, India
Job details
Work flexibility: Hybrid
Req ID: R562868
Employee type:
- Full Time
- Intern
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Job description
- 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
Pay rate will not be below any applicable local minimum wage rates.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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