Manager clinical Affairs

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:

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  Clinical strategy development and global study execution

  
  


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  Preparation of CER, PMCF, PMS, and Clinical Study Reports

  
  


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  Ethics Committee (EC) and Competent Authority (CA) submissions and regulatory support

  
  


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  Site initiation, monitoring, and close-out activities

  
  


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  Strong working knowledge of ISO 14155, ICH-GCP, ISO 13485, and ISO 14971

  
  
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