Qa Ra Specialist

Job Description

• Prepare and review Clinical Evaluation Reports (CERs) for medical devices.
• Conduct systematic literature searches using relevant databases and methodologies.
• Perform State of the Art (SOTA) assessment and clinical data analysis.
• Support clinical evaluation, PMS, PMCF, and regulatory documentation.
• Ensure documentation aligns with applicable medical device regulatory requirements.
• Apply strong technical writing, analytical, and documentation skills to prepare high-quality reports.
• Medical device industry experience with exposure to clinical/regulatory affairs is preferred.