Regulatory Affairs Professional, Database
Danaher Corporation
full-time
Posted on:
Location Type: Remote
Location: India
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About the role
- 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
Requirements
- Master’s degree in 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.)
Benefits
- Health care program
- Paid time off
- Remote work options
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory compliancedata managementdocument controlproduct registrationregulatory systems proficiencyaudit readinessaccuracy verificationtraining provisionglobal regulatory interpretationregulatory standards application
Soft skills
organizational skillscommunication skillsattention to detailproblem-solvingcollaboration