Jitendra Mali
Regulatory Affairs Professional | ROW Market Strategy & Compliance | Driving Global Market Access | ISO 13485 Compliance | Technical Documentation Expert | Regulatory Submissions & Audit Readiness
- Role
- Regulatory Affairs Officer at Meril
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
About Jitendra Mali
I am a Regulatory Affairs Officer with a strong passion for ensuring product compliance…
Experience
Regulatory Affairs Officer
Mar 2025 — Present · Vapi, IN
Prepared and reviewed technical documentation for Class devices (sheaths, Guidewires, stents).• Executed process, sterilization, and packaging validation batches ensuring compliance with regulatory standards.• Addressed regulatory authority queries and ensured timely responses for successful submissions and approvals.• Supported Quality Management System (QMS) development and maintained ISO 13485 compliance.• Developed risk assessments and regulatory strategies to support product approvals.• Collaborated with cross-functional teams to ensure regulatory compliance and adherence to quality requirements.
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