Clinical Validation Co
7 days ago
**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
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