Quality & Clinical Validation Lead

The Quality Assurance & Clinical Validation Lead will be responsible for establishing and maintaining the Quality Management System (QMS) in compliance with ISO 13485 , while simultaneously planning and executing clinical and design validation activities to demonstrate that medical devices meet intended use, user needs, and clinical performance requirements.

This role acts as a critical bridge between R&D, Clinical, Regulatory, and Manufacturing , ensuring that product development is compliant, clinically relevant, and audit-ready.

Key Responsibilities

Quality Assurance & QMS

• Establish, implement, and maintain an ISO 13485:2016 compliant QMS
• Develop, review, and control:
• Quality Manual
• SOPs, Work Instructions, and Forms
• DHF, DMR, and DHR
• Ensure effective implementation of design controls , including:
• Design inputs and outputs
• Design reviews
• Design verification and validation
• Manage Non-Conformances (NCs) , deviations, CAPA, and change control
• Plan and conduct:
• Internal audits
• Supplier audits and qualification
• Management Review meetings
• Ensure inspection and release controls for incoming, in-process, and final products
• Maintain training records and competency matrices
• Support risk management activities as per ISO 14971
• Prepare and support ISO 13485 Stage 1 & Stage 2 audits and regulatory inspections

Clinical Validation & Clinical Research

• Plan, execute, and document clinical validation activities aligned with intended use and user needs
• Develop and manage:
• Clinical Validation Plans
• Validation Protocols and Reports
• Usability validation documentation
• Coordinate with surgeons, clinicians, and key opinion leaders (KOLs) for clinical input and evaluation
• Conduct and oversee:
• Simulated-use studies
• Usability and human factors validation
• Cadaveric / animal studies (if applicable)
• Collect, analyze, and document clinical performance and safety data
• Support preparation of:
• Clinical Evaluation Plans (CEP)
• Clinical Evaluation Reports (CER)
• Post-Market Clinical Follow-Up (PMCF) plans
• Ensure traceability between:
• User needs
• Clinical risks
• Validation evidence
• Feed clinical insights back into design improvement and risk mitigation

Cross-Functional & Regulatory Support

• Work closely with R&D to ensure design outputs are verifiable and clinically relevant
• Coordinate with Regulatory Affairs for submissions in India, EU, and other target markets
• Ensure alignment between clinical data, risk management, and quality documentation
• Support post-market surveillance and complaint trending from a clinical perspective

Required Qualifications

• Bachelors or Masters degree in:
• Biomedical Engineering, Life Sciences, or related field
• OR
• Clinical background (MBBS / BDS / Allied Health Sciences) with medical device experience
• 37 years of experience in:
• Medical Device Quality Assurance and/or
• Clinical Validation / Clinical Research
• Hands-on experience with ISO 13485 and medical device documentation

Key Skills & Competencies

Strong understanding of:

• ISO 13485
• Design controls
• Clinical validation methodologies
• Risk management (ISO 14971)
• Excellent technical documentation and audit handling skills
• Ability to translate clinical feedback into quality and design improvements
• High attention to detail and regulatory discipline
• Comfortable working in a fast-paced startup environment

Why This Role Matters

This role is central to ensuring that:

• Products are safe, effective, and clinically validated
• The organization is audit-ready at all times
• Clinical insights directly strengthen design, usability, and regulatory success

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