Clinical Validation Co -ordinator

Job Summary:

The Clinical Validation Coordinator is responsible for planning, executing, and documenting clinical validation activities for medical devices. This role is well-suited for a nurse or clinical professional looking to transition into the medical device manufacturing industry. The position involves evaluating product performance in real-world clinical settings—through simulations, usability studies, and clinical observations—to ensure safety, effectiveness, and compliance. The coordinator also supports regulatory submissions by generating and analyzing clinical evidence.

Key Responsibilities:

• Plan and execute clinical validation studies, including protocol development, data collection, and analysis.
• Coordinate with hospitals/clinicians for clinical simulation, usability, and in-hospital evaluations.
• Supporting on preparation of Clinical Evaluation Report, clinical validation report for regulatory submission
• Prepare informed consent forms, patient-facing materials, and study documentation.
• Collect user feedback and clinical observations and assist in documentation for risk analysis and product improvement.    
• Analyze clinical feedback and translate it into product improvements or risk mitigations.
• Support post-market clinical follow-up (PMCF) and post-market surveillance (PMS) data collection.
• Assist in root cause analysis and CAPA related to clinical issues.

Requirements:

• Bachelor’s or master degree in Nursing.
• 2–4 years of experience in a hospital, ICU, NICU, or medical device clinical environment.
• Good understanding of medical devices, patient care, and hospital workflows.
• Ability to interact with clinicians and observe medical procedures professionally.
• Basic knowledge of study documentation and ethical requirements (GCP awareness is a plus).
• Good written and verbal communication skills for reporting and coordination.

Job Types: Full-time, Permanent

Pay: From ₹25,000.00 per month

Benefits:

• Health insurance
• Leave encashment
• Provident Fund

Work Location: In person