DHF Remediation-Medical Devices-Technical Lead

2 weeks ago


tamil nadu, India HCLTech Full time

Roles & ResponsibilitiesDHF RemediationConduct DHF Gap Assessments: Review existing DHFs to identify discrepancies, missing information, and non-compliance issues with current regulations.Develop Remediation Plans: Create detailed action plans to address identified gaps, including corrective actions (CA) and preventive actions (PA).Implement Remediation Activities: Execute and oversee remediation plans, collaborating with cross-functional teams to update and create necessary documentation.Ensure Design Control Compliance: Verify that all design and development activities align with regulatory design control requirements throughout the DHF remediation process.Documentation Management: Organize DHF documentation within a centralized system, ensuring version control, traceability, and accessibility.QualificationBachelor's degree in Mechanical / Biomedical / Software / Hardware Engineering, Quality Assurance, Regulatory Affairs, or related field.Key SkillsMDRDHF RemediationGAP AnalysisPreferred Candidate ProfileCandidates willing to attend the face-to-face physical weekend drive on Nov 15th, 2025 (Saturday) at our Madurai office premises.



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