DHF Remediation-Medical Devices-Technical Lead

Roles & Responsibilities

DHF Remediation

• 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

  .