Ensure clinical investigations comply with ISO 14155 2020 and ICH-GCP guidelines Oversee regulatory submissions and study approvals in alignment with the Current Drugs and Clinical Trials Rules NDCTR 2019 Coordinate biocompatibility evaluations following ISO 10993-1 requirements Support risk management activities as per ISO 14971 and ISO 24971 Prepare and maintain clinical study documentation protocols and reports Conduct internal audits and compliance checks to ensure adherence to global and local regulatory standards Collaborate with clinical teams regulatory authorities and ethical committees for study execution and approvals Provide training on clinical compliance regulatory updates and quality system requirements
📌 Medical & Regulatory Writer (Ahmedabad)
🏢 United HR Solutions
📍 Ahmedabad
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