Zydus Medtech Private Limited is currently hiring Clinical QMS Coordinator and Clinical Operations Associate for its MedTech office in Ahmedabad, Gujarat. These opportunities are ideal for life sciences professionals interested in clinical operations, medical device clinical investigations, regulatory compliance, and clinical quality management systems (CQMS).
The roles focus on supporting clinical trials, quality management systems, and regulatory documentation aligned with ISO 13485, ISO 14155, EU MDR, and India Medical Device Rules. Candidates with backgrounds in pharmacy, biomedical engineering, life sciences, or clinical research are encouraged to apply.
These positions offer an excellent opportunity to work in the medical device regulatory and clinical research ecosystem, ensuring compliance, patient safety, and high-quality clinical documentation.
Available Positions
1. Clinical QMS Coordinator โ Medical Devices
Role Overview
The Clinical QMS Coordinator will establish and maintain a Clinical Quality Management System (CQMS) aligned with ISO 13485 and ISO 14155 standards. The role ensures that all clinical activities including clinical evaluations, clinical investigations, and post-market surveillance comply with global regulatory requirements.
Key Responsibilities
- Develop and maintain clinical QMS documentation, including SOPs and quality manuals.
- Ensure audit readiness and document control for clinical operations.
- Manage Electronic Essential Clinical Investigation Documents File (eECIDF).
- Conduct internal audits of clinical sites, CROs, and vendors.
- Implement Corrective and Preventive Actions (CAPA) for deviations and non-conformances.
- Integrate risk management (ISO 14971) into clinical processes.
- Support regulatory inspections and health authority audits.
- Deliver GCP and regulatory training programs to internal teams.
Required Qualifications
- Bachelorโs degree in Life Sciences, Engineering, Nursing, or related field
- Masterโs degree preferred
- 5โ8+ years experience in QA, Regulatory Affairs, or Clinical Operations
- Strong knowledge of
- ISO 14155 (Clinical Investigation of Medical Devices)
- ISO 13485
- ICH-GCP E6
- EU MDR and FDA QSR
Preferred Certifications
- Certified Quality Auditor (CQA)
- Certified Quality Engineer (CQE)
- Regulatory Affairs Certification (RAC)
2. Clinical Operations Associate (COA)
Role Overview
The Clinical Operations Associate supports clinical investigation documentation, study coordination, and regulatory compliance for medical device clinical trials.
The position ensures clinical files are maintained according to ISO 14155, EU MDR 2017, and India Medical Device Rules 2017.
Key Responsibilities
- Manage Product Clinical Module files as per IMDRF STED Module V
- Maintain Essential Clinical Investigation Documentation Files (ECIDF)
- Support study startup activities, including documentation preparation
- Track clinical study metrics, dashboards, and reports
- Coordinate clinical site communication and documentation collection
- Support audit preparation and GCP compliance
- Assist in vendor coordination and clinical supplies management
Required Qualifications
- Bachelorโs degree in
- Pharmacy
- Medicine
- Nursing
- Biomedical Engineering
OR
- Masterโs degree in
- Biotechnology
- Toxicology
- Biology
- Statistics
Required Skills
- Knowledge of ISO 14155:2020 clinical investigation requirements
- Understanding of India MDR 2017 Schedule 7 & 8
- Familiarity with IMDRF STED methodology
- Proficiency in Microsoft Office, SharePoint, OneDrive, and Excel
- Strong documentation, organization, and communication skills
Salary and Benefits
Estimated salary ranges (industry standard):
- Clinical QMS Coordinator: โน8,00,000 โ โน14,00,000 per year
- Clinical Operations Associate: โน3,50,000 โ โน6,00,000 per year
Benefits may include:
- Medical insurance
- Clinical research training opportunities
- Exposure to global regulatory frameworks
- Professional development programs
- Work with experienced medical device regulatory teams
Job Location
Ahmedabad, Gujarat, India
MedTech Office โ Zydus Medtech
How to Apply
Application Link Clinical QMS Coordinator
Application Link Clinical Operations Associate