Job Description:

Department: Clinical Affairs

Job Title: Executive / Sr. Executive

Role: Clinical QA

Experience Required: 3–5 Years

Job Location: Corporate Office, Ahmedabad

Role Objective:
- To safeguard the quality, accuracy, and regulatory compliance of clinical study documentation across the product portfolio through systematic quality assurance review, SOP governance, audit representation, ISO gap analysis, vendor/CRO oversight, and error, deviation, and CAPA tracking. The role supports audit readiness, data integrity, and compliant execution of medical-device clinical investigations in coordination with Clinical Operations, Medical Writing, Regulatory Affairs, and Data Management.

Role and Responsibilities:

Study Document Quality Assurance
- Conduct quality assurance review of clinical study documents across the medical-device clinical investigation lifecycle, from medical writing through study closeout, including Clinical Investigation Plans/protocols, CRFs, ICFs, Clinical Investigation Reports / CSRs, PMCF Plans and Trial Master Files.




- Review documents for accuracy, completeness, consistency and compliance with ISO 14155 and applicable regulatory requirements.
- Ensure clinical documentation is maintained in a state of audit readiness and is traceable to technical documentation and Post-Market Clinical Follow-up (PMCF) requirements under EU MDR 2017/745.

SOP Development, Review and Update
- Draft, periodically review and update Standard Operating Procedures (SOPs) governing medical-device clinical trials in line with ISO 14155 and ISO 13485 quality-management-system requirements.
- Develop and maintain QA checklists, review logs and document-control templates aligned with the medical-device lifecycle and applicable design-control expectations, including 21 CFR 820 / ISO 13485.
- Support consistent implementation of approved SOPs and quality controls within Clinical Affairs.

Audit Representation - Internal and External
- Represent and support Clin

📌 Senior Executive (Ahmedabad)
🏢 Biotech Healthcare
📍 Ahmedabad