Clinical QMS Coordinator & Clinical Operations Associate
🏢 About Zydus Medtech
Zydus Medtech Private Limited is a part of the Zydus Group and focuses on developing advanced medical technologies and devices. The company operates in the medical device clinical research ecosystem and ensures global regulatory compliance aligned with ISO 13485, ISO 14155, EU MDR, and India Medical Device Rules.
📌 Job Overview
- Company: Zydus Medtech
- Location: Ahmedabad, Gujarat
- Available Roles: Clinical QMS Coordinator & Clinical Operations Associate
- Experience: 0 – 8 Years
- Industry: Medical Devices / Clinical Research
- Employment Type: Full-Time
🔬 Role 1: Clinical QMS Coordinator
This role focuses on maintaining Clinical Quality Management Systems (CQMS) for medical device clinical investigations.
- Develop and maintain clinical QMS documentation
- Ensure compliance with ISO 13485 and ISO 14155
- Manage Electronic Essential Clinical Investigation Documents
- Conduct internal audits of clinical sites and vendors
- Implement CAPA for deviations and non-conformances
- Support regulatory inspections and audits
- Deliver GCP and regulatory training
Experience Required: 5–8+ years in QA, regulatory affairs, or clinical operations.
📊 Role 2: Clinical Operations Associate
The Clinical Operations Associate supports clinical investigation documentation and study coordination for medical device trials.
- Maintain Essential Clinical Investigation Documentation Files
- Manage Product Clinical Module files
- Support study startup documentation
- Track study metrics and reports
- Coordinate clinical site communication
- Assist audit preparation and regulatory compliance
- Support vendor coordination and clinical supply management
🎓 Eligibility Criteria
- B.Pharm / M.Pharm / PharmD
- Medicine / Nursing
- Biomedical Engineering
- BSc / MSc Life Sciences
- Biotechnology / Toxicology / Biology
- Statistics
⭐ Salary & Benefits
- Clinical QMS Coordinator: ₹8 – ₹14 LPA
- Clinical Operations Associate: ₹3.5 – ₹6 LPA
- Medical insurance and healthcare benefits
- Exposure to global regulatory frameworks
- Clinical research training programs
- Professional development opportunities
🎯 Clinical Research Interview Preparation Tips
- Understand ISO 14155 clinical investigation requirements
- Review India Medical Device Rules (MDR 2017)
- Learn clinical documentation and ECIDF structure
- Study GCP guidelines and regulatory compliance
Helpful learning resources:
Kindly read the job description carefully before applying and ensure your qualifications match the role requirements.
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