Anshini Pandey
Biotech Engineer | Regulatory Affairs | ISO 13485 | GSPR | Technical & Regulatory Documentation | Medical Device Compliance
- Role
- Regulatory Affairs Executive at Poly Medicure Ltd
- Location
- Faridabad, HR, IN
- LinkedIn followers
- 500 followers
About Anshini Pandey
Biotechnology engineering graduate working as Regulatory Affairs Executive at…
Experience
Regulatory Affairs Executive
Dec 2024 — Present · Faridabad, IN
Preparing and maintaining high-quality technical documentation in compliance with ISO 13485 and EU MDR requirements.Working closely with cross-functional teams to compile and update documents like GSPR, risk management files, design dossiers, and technical files.Supporting regulatory submissions and audits by ensuring documentation is accurate, complete, and audit-ready.Managing documentation workflows, change controls, and version tracking for critical quality records.Contributing to the continuous improvement of documentation systems and ensuring alignment with global regulatory expectations.
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