About the Role
The individual will manage regulatory submissions, maintain compliance with Indian health authority requirements, and support product lifecycle management across multiple jurisdictions.
Responsibilities
- Lead regulatory strategy development for product approvals in India
- Prepare and submit applications to Indian regulatory agencies
- Ensure compliance with CDSCO and other local regulatory standards
- Collaborate with quality and clinical teams on product documentation
- Monitor changes in national and regional regulations
- Provide regulatory input during product design and development phases
- Manage post-market regulatory obligations including adverse event reporting
- Coordinate with external consultants and testing laboratories
- Support audits and inspections by regulatory authorities
- Maintain up-to-date knowledge of medical device and software regulations
- Guide internal teams on regulatory implications of product changes
- Oversee labeling and promotional material compliance
- Facilitate communication between global regulatory teams and local stakeholders
- Track submission timelines and resolve agency queries
- Ensure alignment with international regulatory harmonization initiatives
- Assist in classification and risk assessment of new products
- Develop and maintain regulatory databases and tracking systems
- Train functional teams on regulatory requirements
- Participate in due diligence for new product acquisitions
- Contribute to regulatory aspects of mergers and integrations
Compensation
Competitive salary and benefits package
Work Arrangement
Hybrid work model with flexibility based on role and location
Team
Part of a global regulatory affairs team within a growing healthcare technology organization
Why Join Us
- Opportunity to shape regulatory strategy in a fast-evolving healthcare technology environment
- Work alongside global experts in regulatory science and product development
- Be part of an innovative team integrating AI into medical solutions
- Support transformative products from concept to market approval
Growth Opportunities
- Access to professional development programs and regulatory training
- Pathways for advancement within the global regulatory organization
- Exposure to international regulatory networks and forums
- Leadership roles in cross-regional projects
Available for qualified candidates requiring sponsorship
