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 Trial Master Files
- Knowledge of ISO 14155, ICH-GCP, EU MDR 2017/745, ISO 13485, ISO 11979 and applicable regulatory requirements
- SOP drafting, review, document control and QA checklist development
- Internal, external, notified-body and regulatory audit/inspection support
- Vendor / CRO qualification, due diligence and sponsor-oversight review
- Gap analysis, deviation / non-conformity tracking and CAPA management
- Clinical documentation traceability, audit readiness and data-integrity controls
- Cross-functional coordination with Clinical Operations, Medical Writing, Regulatory Affairs and Data Management
Behavioural Skills Required:
- Strong attention to detail and quality orientation
- Analytical thinking and structured problem-solving
- Clear written and verbal communication
- Effective cross-functional collaboration and stakeholder coordination
- High process discipline, accountability and timely action closure
- Ability to prioritize multiple quality-review activities in a dynamic environment
- Integrity, compliance mindset and commitment to clinical data quality
Team Size to be Handled:
- Individual Contributor role, reporting to AGM - Clinical Affairs.
Specific Professional Competencies:
- Quality Orientation, Attention to Detail, Analytical Thinking, Problem-solving, Regulatory Compliance, Audit Readiness, Documentation Control, Cross-functional Collaboration, Communication Skills, Functional / Technical Skills, Adherence to Ethics and Values, Integrity.
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Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.