Job Description

Job Description:

n

Department: Clinical Affairs

n

Job Title: Executive / Sr. Executive

n

Role: Clinical QA

n

Experience Required: 3–5 Years

n

Job Location: Corporate Office, Ahmedabad

n

n

Role Objective:

n

- n
- 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

n

n

Role and Responsibilities:

n

Study Document Quality Assurance

n

- n
- 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

n

SOP Development, Review and Update

n

- n
- 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

n

Audit Representation - Internal and External

n

- n
- Represent and support Clinical Affairs during internal, external, notified-body and regulatory audits and inspections.n
- Coordinate with internal stakeholders to address audit queries and provide QA evidence,



review logs and supporting clinical documentation.n
- Support inspection readiness in accordance with ISO 14155, EU MDR and applicable Health Authority requirements, including US FDA and CDSCO.n

n

Vendor Audit and Due Diligence

n

- n
- Support vendor / CRO due-diligence and qualification activities along with the internal team.n
- Review vendor and CRO clinical deliverables for quality and compliance prior to acceptance, consistent with sponsor-oversight obligations under ISO 14155.n
- Track identified vendor-quality observations and support timely closure of agreed actions.n

n

Gap Analysis, Error, Deviation and CAPA Tracking

n

- n
- Perform gap analysis against applicable standards and regulatory requirements, including ISO 14155, ISO 13485, ISO 11979 and related clinical-quality requirements.n
- Identify and document compliance gaps and coordinate remediation actions with relevant stakeholders.n
- Log, trend, investigate and close document-level errors, deviations and non-conformities identified during QA review.n
- Support and track Corrective and Preventive Actions (CAPA) and provide periodic quality-status reporting to management.n

n

Regulatory Knowledge and Cross-functional Coordination

n

- n
- 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.n
- Liaise with Medical Writing, Regulatory Affairs, Clinical Operations and Data Management teams to resolve documentation gaps and quality observations.n
- Ensure clinical evidence and QA-reviewed documentation are appropriately aligned for regulatory submissions and technical-file requirements.n
- Maintain effective communication and documentation control across Clinical Affairs and relevant cross-functional teams.n




- Perform other related duties as assigned by the reporting manager.n

n

n

Functional Skills Required:

n

- n
- Clinical Quality Assurance for medical-device clinical investigationsn
- Quality review of clinical study documents, protocols, CRFs, ICFs, CSRs / Clinical Investigation Reports, PMCF Plans and Trial Master Filesn
- Knowledge of ISO 14155, ICH-GCP, EU MDR 2017/745, ISO 13485, ISO 11979 and applicable regulatory requirementsn
- SOP drafting, review, document control and QA checklist developmentn
- Internal, external, notified-body and regulatory audit/inspection supportn
- Vendor / CRO qualification, due diligence and sponsor-oversight reviewn
- Gap analysis, deviation / non-conformity tracking and CAPA managementn
- Clinical documentation traceability, audit readiness and data-integrity controlsn
- Cross-functional coordination with Clinical Operations, Medical Writing, Regulatory Affairs and Data Managementn

n

n

Behavioural Skills Required:

n

- n
- Solid attention to detail and quality orientationn
- Analytical thinking and structured problem-solvingn
- Clear written and verbal communicationn
- Effective cross-functional collaboration and stakeholder coordinationn
- High process discipline, accountability and timely action closuren
- Ability to prioritize multiple quality-review activities in a dynamic environmentn
- Integrity, compliance mindset and commitment to clinical data qualityn

n

n

Team Size to be Handled:

n

- n
- Individual Contributor role, reporting to AGM - Clinical Affairs.n

n

n

Specific Professional Competencies:

n

- n
- 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.n

n

Important Links:

n

- n
- Website: https://biotechhealthcare.com/n
- LinkedIn: https://www.linkedin.com/company/biotechhealthcare/n
- Instagram: Biotech Vision Caren

n

n

Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.

📌 Senior Executive - Clinical QA (India)
🏢 Biotech Healthcare
📍 India