Senior Engineers

17 hours ago

Chennai Bengaluru Pune, India Citiustech Healthcare Technology Private Limited Full time

Job Description An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality including Software as a Medical Device (SaMD). The ideal candidate will have 310 years of hands-on experience in regulatory strategy, quality systems, and compliance for digital health products and medical device software. This role is critical in ensuring our SaMD offerings meet global regulatory and quality standards across the product lifecycle. Key Responsibilities: - Develop and execute regulatory strategies for medical devices including SaMD products across global markets (FDA, EU MDR, etc.). - Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, IEC 62304, IEC 82304, and EU MDR. - Prepare regulatory submissions including 510(k), CE Mark. - Maintain and improve Quality Management Systems (QMS) aligned with industry best practices. - DHF documentation including software design documents and verification/ validation activities. - Lead risk management processes. - Collaborate with cross-functional teams including product development, clinical, and manufacturing during project executions. - Stay updated on regulatory changes and ensure timely implementation. - Experience with usability engineering and usability standards (IEC 62366) Required Qualifications: - Bachelors or masters degree in engineering, Life Sciences, or related field. - 310 years of experience in Med Device QARA with Software Quality including SaMD. - Strong understanding of Design controls, DHF, SDLC, software validation, and regulatory frameworks for digital health. - Proven track record of successful regulatory submissions and audit readiness. - Excellent communication, documentation, and leadership skills. Must Have skill:QARA + SaMD

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