QARA + SaMD Specialist

2 days ago

Chennai Bengaluru Mumbai, India Aegan Technologies Private Limited Full time

Job Description Job Title: QARA + SaMD Specialist (Contract Role) Company: Aegan Technologies Locations: Pune | Chennai | Bangalore | Mumbai | Hyderabad Experience: 3 to 10 Years Join Within: 15 Days Job Description: Aegan Technologies is hiring experienced QARA + SaMD Specialists for a contract-based opportunity. 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

  • QARA + SaMD Specialist

    2 days ago

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