Job Description
Job Description:
nDepartment: Clinical Affairs
nJob Title: Executive / Sr. Executive
nRole: Clinical QA
nExperience Required: 3–5 Years
nJob Location: Corporate Office, Ahmedabad
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nRole Objective:
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- 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.n

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nRole and Responsibilities:
nStudy Document Quality Assurance
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- 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.n
- Review documents for accuracy, completeness, consistency and compliance with ISO 14155 and applicable regulatory requirements.n
- 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.n

nSOP Development, Review and Update
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- 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.n
- 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.n
- Support consistent implementation of approved SOPs and quality controls within Clinical Affairs.n

📌 Senior Executive (India)
🏢 Biotech Healthcare
📍 India