Staff Regulatory Affairs
India
Fully remote working arrangement within IndiaFull-TimeStaff
Salary not disclosed
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Job Details
- Experience
- 10+ years of experience
- Required Skills
- Artificial Intelligence
Requirements
- Master’s degree in life sciences, engineering, or a related field; advanced degree preferred
- 10+ years of experience in regulatory affairs or regulatory intelligence within IVD or medical device industries
- Strong knowledge of global regulatory frameworks including FDA, EU IVDR, ISO 13485, ISO 20916, and related standards
- Experience managing regulatory compliance programs, audit readiness, and tracking systems
- Familiarity with regulatory intelligence tools, digital platforms, or AI-enabled monitoring systems
- Strong analytical, communication, and stakeholder management skills
- Experience with AI/software or chemical/environmental regulations is a strong advantage
- Exposure to regulatory agency interactions or notified bodies is a plus
Responsibilities
- Monitor and analyze global regulatory frameworks across IVD, medical devices, software, and environmental/chemical regulations (FDA, EU IVDR, REACH, RoHS, ISO standards, etc.)
- Develop detailed regulatory impact assessments and translate changes into actionable business recommendations
- Support regulatory strategy by providing intelligence-driven insights and maintaining regulatory dashboards and tracking systems
- Prepare executive summaries, compliance reports, and regulatory briefings for internal stakeholders
- Conduct compliance gap analyses and risk assessments in collaboration with Quality and Legal teams
- Ensure alignment with internal SOPs and global regulatory requirements while supporting audit readiness and compliance programs
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