Division

- MedTech Office
- Job posted on
- Mar 12, 2026
- Employee Type
- P-P8-Probationer-HO Executive
- Experience range (Years)
- 0 - 0

Job Summary

The Clinical QMS coordinator for Medical Devices Shall be responsible for establishing, implementing, and maintaining a robust Clinical Quality Management System (CQMS), within the larger organization’s QMS aligned with ISO 13485. This role ensures that all clinical activities including clinical experience, clinical evaluation, clinical immersion, and investigations (pre

- and post-market) are conducted, recorded, and reported in accordance with applicable regulatory requirements ISO 13485:2016-2025, EU ISO23604, and ISO 14155 standards and their regulatory requirements in Europe, India, US and other geographies. The manager shall drive a culture of continuous audit readiness, data integrity, and patient safety.

Key Responsibilities

1. Clinical QMS Development and Maintenance

- Develop, update, and maintain Quality Manuals, SOPs, and work instructions specifically for clinical operations, ensuring alignment with ISO 13485 and ISO 14155.
- Ensure all clinical documentation is controlled, standardized, and audit ready.
- Oversee the electronic Essential Clinical Investigation Documents File(eECIDF) for completeness and accuracy.

2. Audit and Inspection Readiness

- Plan and execute a risk-based internal audit program for clinical sites and vendor/CRO activities.
- Lead readiness initiatives, acting as the primary point of contact during health authority inspections and audits.
- Conduct gap assessments and implement corrective actions following internal reviews or regulatory inspections.

3. Risk Management and CAPA

- Integrate risk management principles (ISO 14971) into clinical processes, such as identifying risks to patient safety or data integrity.




- Manage the CAPA (Corrective and Preventive Action) process for clinical deviations and non-conformances, ensuring effective root cause analysis and action closure.
- Investigate deviations from protocols, Valuable Clinical Practice (GCP), or regulatory requirements.

4. Vendor and Clinical Site Oversight

- Establish and manage vendor qualification programs, including conducting quality audits of CROs and external labs.
- Maintain oversight of vendor performance against established Quality Agreements.
- Ensure investigator site staff are trained and compliant with study protocols.

5. Training and Mentorship

- Develop and deliver GCP/regulatory training programs for internal clinical teams and external stakeholders.
- Foster a culture of quality, providing guidance on best practices for clinical excellence.

Qualifications and Requirements

- Education : Bachelor’s degree in Life Sciences, Engineering, Nursing, or related field; Master’s preferred.
- Experience : Minimum 5-8+ years in Quality Assurance, Regulatory Affairs, or Clinical Operations within the medical device or pharmaceutical industry.
- Regulatory Knowledge : Deep understanding of ISO 14155 (clinical investigation of medical devices), ISO 13485, ICH-GCP (E6 R2/R3), FDA QSR, and EU MDR.
- Skills : Strong analytical, project management, and root cause analysis skills.
- Certifications : Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or RAC certification is highly desirable.

Essential Skills

- Excellent Communication : Ability to communicate complex quality issues to senior management and diverse teams.
- Detail-Oriented : Meticulous approach to document review and data analysis.
- Problem-Solving : Capable of creating pragmatic, compliant solutions under pressure.
- Travel : Ability to travel (approx. 30-40%) for audits and site visits.
- Quality Management System (QMS) For Clinical Trials

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