DHF Remediation

2 days ago


Madurai, Tamil Nadu, India HCLTech Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Roles & Responsibilities

  • Conduct 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.

Qualification

  • Bachelor's degree in Mechanical / Biomedical / Software / Hardware Engineering, Quality Assurance, Regulatory Affairs, or related field.

Key Skills

  • MDR
  • DHF Remediation
  • GAP Analysis

Preferred Candidate Profile

  • Candidates willing to attend the face-to-face physical weekend drive on Nov 15th, 2025 (Saturday) at our Madurai office premises.


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