3 Years, SaMD in Regulatory, IMMEDIATE JOINER. Across India
6 days ago
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: < 10 LPA 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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Bengaluru, India Whatjobs IN C2 Full timeQualBizz 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: < 10 LPA Job Summary: An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality,...
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Bengaluru, India QualBizz Solutions Full timeQualBizz is looking for Immediate joiners for its client. Email to HRindia@qualbizz.com 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...
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Bengaluru, India QualBizz Solutions Full timeQualBizz 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: < 10 LPA Job Summary: An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality,...
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Bengaluru, India QualBizz Solutions Full timeQualBizz is looking for Immediate joiners for its client. Email to HRindia@qualbizz.com NO SaMD experience, DO NOT WASTE TIME sharing/applying. 3 years of experience with multiple positions. Hybrid, Multiple Locations across India CTC: < 10 LPA Job Summary: An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device...
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Bengaluru, India QualBizz Solutions Full timeQualBizz 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 IndiaCTC:Job Summary:An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality, including...
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Bengaluru, India QualBizz Solutions Full timeQualBizz is looking for Immediate joiners for its client. Email to SaMD experience, DO NOT WASTE TIME sharing/applying.3 years of experience with multiple positions.Hybrid, Multiple Locations across IndiaCTC:Job Summary:An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device software quality, including ...
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Bengaluru, India QualBizz Solutions Full timeQualBizz is looking for Immediate joiners for its client. Email to HRindia@qualbizz.comNO SaMD experience, DO NOT WASTE TIME sharing/applying.3 years of experience with multiple positions. Hybrid, Multiple Locations across IndiaCTC: < 10 LPAJob Summary:An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device...
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Bengaluru, India QualBizz Solutions Full timeQualBizz is looking for Immediate joiners for its client. Email to HRindia@qualbizz.comNO SaMD experience, DO NOT WASTE TIME sharing/applying.3 years of experience with multiple positions. Hybrid, Multiple Locations across IndiaCTC: < 10 LPAJob Summary:An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device...
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Bengaluru, India QualBizz Solutions Full timeQualBizz is looking for Immediate joiners for its client. Email to HRindia@qualbizz.comNO SaMD experience, DO NOT WASTE TIME sharing/applying.3 years of experience with multiple positions. Hybrid, Multiple Locations across IndiaCTC: < 10 LPAJob Summary:An experienced Quality Assurance and Regulatory Affairs (QARA) professional specializing in Med Device...
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QARA + SaMD Specialist
4 weeks ago
Chennai, Bengaluru, Mumbai, India Aegan Technologies Private Limited Full timeJob 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...
