Joiners / Carpenter - Immediate starts

3 hours ago


Bangalore, India QualBizz Solutions Full time

QualBizz is looking for Immediate joiners for its client. Email to NO SaMD experience, DO NOT WASTE TIME sharing/applying. 3 years of experience with multiple positions. Hybrid, Multiple Locations across India CTC: Job Summary: 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 3 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,s 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: • Bachelor’s or master’s degree in engineering, Life Sciences, or related field. • 3 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.



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