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 Clinical Affairs during

📌 Senior Executive (Mumbai)
🏢 Biotech Healthcare
📍 Mumbai