Job Description
Responsible for end-to-end planning, execution, and oversight of pre- and post-market clinical investigations for medical devices, ensuring compliance with CDSCO, EU MDR, ISO 14155, ICH-GCP, and NDCT-2019. Drives clinical strategy, protocol development, investigator and site management, and regulatory deliverables including CER, PMCF, PMS, and CSR, generating robust clinical evidence to support regulatory approvals and post-market surveillance.
Key Responsibilities / Skills:
Clinical strategy development and global study execution
Preparation of CER, PMCF, PMS, and Clinical Study Reports
Ethics Committee (EC) and Competent Authority (CA) submissions and regulatory support
Site initiation, monitoring, and close-out activities
Strong working knowledge of ISO 14155, ICH-GCP, ISO 13485, and ISO 14971
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