QARA + SaMD Specialist
4 weeks ago
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
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QARA + SaMD Specialist
7 days ago
Mumbai, Maharashtra, India Aegan Technologies Private Limited Full time ₹ 6,00,000 - ₹ 18,00,000 per yearAegan Technologies Hiring: QARA + SaMD Specialist (Contract Role)Locations: Pune | Chennai | Bangalore | Mumbai | HyderabadJoin Within: 15 DaysAbout the Role:Aegan Technologies is looking for experienced QARA + SaMD (Software as a Medical Device) professionals for a contract-based opportunity. The ideal candidate will play a key role in ensuring regulatory...
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Senior Engineers
17 hours ago
Chennai, Bengaluru, Pune, India Citiustech Healthcare Technology Private Limited Full timeJob 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....
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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 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 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 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,...
