Posted:3 days ago| Platform: Foundit logo

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Job Description

Job Title:

QARA + SaMD Specialist (Contract Role)

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QARA + SaMD Specialists

The ideal candidate will be responsible for managing regulatory strategies, ensuring compliance with global standards (FDA, EU MDR, ISO, IEC), and maintaining QMS and DHF documentation for software-based medical devices.

Key Responsibilities:

  • Manage regulatory and quality processes for medical devices & SaMD.
  • Ensure compliance with FDA QSR, ISO 13485, ISO 14971, IEC 62304, IEC 82304 & EU MDR.
  • Prepare regulatory submissions like 510(k) and CE Mark.
  • Maintain QMS and DHF documentation.
  • Lead risk management and software validation activities.
  • Collaborate with cross-functional teams to ensure compliance.

Skills Required:

  • QARA + SaMD expertise
  • Knowledge of Design Controls, DHF, SDLC & Software Validation
  • Experience in Regulatory Submissions & Audit Readiness
  • Strong Communication & Documentation skills

Education:

Bachelor's degree in engineering, Life Sciences, Biomedical, or related field.

Interested Candidates Apply at [HIDDEN TEXT] / +91 9677254444

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