Senior Executive - Clinical QA

Location: Sabarmati

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 internal, external, notified-body and regulatory audits and inspections.
Coordinate with internal stakeholders to address audit queries and provide QA evidence, review logs and supporting clinical documentation.
Support inspection readiness in accordance with ISO 14155, EU MDR and applicable Health Authority requirements, including US FDA and CDSCO.
Vendor Audit and Due Diligence
Support vendor / CRO due-diligence and qualification activities along with the internal team.
Review vendor and CRO clinical deliverables for quality and compliance prior to acceptance, consistent with sponsor-oversight obligations under ISO 14155.
Track identified vendor-quality observations and support timely closure of agreed actions.
Gap Analysis, Error, Deviation and CAPA Tracking
Perform gap analysis against applicable standards and regulatory requirements, including ISO 14155, ISO 13485, ISO 11979 and related clinical-quality requirements.
Identify and document compliance gaps and coordinate remediation actions with relevant stakeholders.
Log, trend, investigate and close document-level errors, deviations and non-conformities identified during QA review.
Support and track Corrective and Preventive Actions (CAPA) and provide periodic quality-status reporting to management.
Regulatory Knowledge and Cross-functional Coordination
Apply working knowledge of ISO 14155 (Good Clinical Practice for Medical Devices), ICH-GCP, EU MDD / MDR 2017/745, ISO 13485, ISO 11979 and other applicable clinical quality standards.
Liaise with Medical Writing, Regulatory Affairs, Clinical Operations and Data Management teams to resolve documentation gaps and quality observations.
Ensure clinical evidence and QA-reviewed documentation are appropriately aligned for regulatory submissions and technical-file requirements.
Maintain effective communication and documentation control across Clinical Affairs and relevant cross-functional teams.
Perform other related duties as assigned by the reporting manager.

Functional

Skills Required:

Clinical Quality Assurance for medical-device clinical investigations
Quality review of clinical study documents, protocols, CRFs, ICFs, CSRs / Clinical Investigation Reports, PMCF Plans and…