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Regulatory Affairs Professional, Database
Location
India
Posted
88 days ago
Salary
0
Seniority
Senior
Job Description
Regulatory Affairs Professional, Database
Danaher Corporation
• Manage and keep the Regulatory database audit-ready and maintain accurate product records • Handle intake of registration requests and coordinate timely follow-up actions • Monitor compliance progress to ensure updates are completed on time and meet regulatory standards • Verify accuracy of entries and archive documentation per company and regulatory procedures • Provide training and ongoing assistance to ensure effective and compliant database use
Job Requirements
- Master’s degree, e.g., engineering, biotechnology, pharmaceutical sciences, medical technology, or similar science field
- Experience in Regulatory Affairs within the medical device or diagnostics industry
- Proficiency in regulatory systems/tools (e.g., electronic submission platforms, document control systems)
- Familiarity with global regulatory frameworks and product registration processes within life sciences
- Ability to interpret and apply global regulatory requirements (EU MDR, IVDR, FDA, Health Canada, PMDA, etc.)
- Familiarity with commercial product lifecycle strategies and market access planning
Benefits
- Health care programs
- Paid time off
- Remote work arrangement
- Bonus/incentive pay
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