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Senior Regulatory Affairs Specialist
Location
India
Posted
87 days ago
Salary
0
Seniority
Senior
Job Description
Senior Regulatory Affairs Specialist
Danaher Corporation
• Manage India regulatory activities for medical devices, including registrations, renewals, variations, labelling compliance and lifecycle management • Compile and submit registration documents, liaise with regulatory authorities and consultants to ensure timely approvals • Assess regulatory impact of post-approval changes including design changes, labeling changes, warehouse changes, supplier or manufacturing site changes • Support post‑market regulatory activities, including Adverse Event reporting, Field Safety Corrective Action (FSCA)/Recall • Monitor and communicate regulatory intelligence and assess impact; maintain regulatory documentation and databases, utilize Regulatory Information Management Systems (Veeva RIM) • Support assigned regulatory activities across ASEAN markets to enable compliance and business objectives
Job Requirements
- Bachelor’s Degree/ Diploma in Life Sciences, Engineering or other related discipline
- Minimum 3 years of RA experience within medical device industry
- Experience with India CDSCO submissions for medical devices
- Good knowledge of India MDR & ASEAN regulatory frameworks
- Working knowledge of ISO 13485 requirements
- Strong written and communication skills
- Ability for minimal travel required at 10% or less within India and abroad
Benefits
- Health care program
- Paid time off
- Flexible working arrangements
- Professional development opportunities
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