Role Overview:

Lead clinical and regulatory documentation and clinical evidence generation for non-active implantable medical devices. Responsible for authoring EU MDR–compliant clinical documents and supporting the design, execution, and oversight of pre- and post-market clinical studies.

Key Responsibilities:

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  Author and maintain CER, CEP, PMCF, PMS, PSUR, and SSCP documentation as per EU MDR.

  
  


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  Conduct literature reviews, risk–benefit analyses, and state-of-the-art assessments.

  
  


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  Draft clinical protocols, study reports, and regulatory submission documents.

  
  


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  Support and oversee clinical study operations, vendors, and CROs.

  
  


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  Collaborate cross-functionally to support regulatory compliance and evidence strategy.