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
Bachelor’s or Master’s degree in:
Biomedical Engineering, Life Sciences, or related field
OR
Clinical background (MBBS / BDS / Allied Health Sciences) with medical device experience
3–7 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

Apply via this Google Form (Use the "Apply for this Job" box below)./vXJqaXvtER2

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