Job Description

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