Risk Management Specialist
1 week ago
Tata Elxsi is truly your home to a billion possibilities. We believe in opportunities for everyone to be bold and curious and seek to shape the future. Explore what’s possible, discover what you love to do, and find accelerated paths for growth. At Tata Elxsi, you matter.Roles and Responsibilities:Develop and maintain risk management plans, procedures, and frameworks in compliance with ISO 14971.Ensure risk management activities align with FDA 21 CFR Part 820.30 and ISO 13485 design control requirements.Lead comprehensive risk analysis and mitigation forHazard identificationDesign FMEA (dFMEA)Use FMEA (uFMEA)Product risk analysis and controlIntegrate risk controls into the design and development process to ensure safety and compliance.Collaborate with design, clinical, regulatory, and quality teams to assess and mitigate risks throughout the product lifecycle.Provide risk-related input during design reviews, change control boards, and technical discussions.Create and maintain risk files, traceability matrices, and risk-benefit analyses.Ensure compliance with IEC 60601, ISO 80601 and ISO 14971 standards for electromechanical and respiratory devices.Maintain clear, audit-ready documentation of risk assessments and mitigation strategies.Participate in internal and external audits, representing risk management documentation and processes.Experience with requirements and traceability tools such as IBM DOORS and Windchill.Education & Skills preferred:MTech / ME / BE / BTech in Biomedical, Electrical, Mechanical, Systems Engineering, or related6–10 years of experience in medical device development, with at least 4-5 years focused on risk management.Strong understanding of ISO 14971, IEC 60601, ISO 13485, and FDA Quality SystemExperience with electromechanical systems and respiratory therapy devices is highly preferred.Strong analytical, documentation, and communication skills.
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Lead Specialist- Enterprise Risk Management
1 week ago
Pune, Maharashtra, India Quest Business Solution Full time ₹ 12,00,000 - ₹ 36,00,000 per yearPosition Summary:We are seeking a dynamic and experienced professional for the role of Lead Specialist/Sr Lead Specialist in Enterprise Risk Management. The ideal candidate will be responsible for identifying, assessing, and mitigating risks across the organization. This role involves analyzing risk trends, developing risk management frameworks, creating...
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FBS Risk Management Specialist
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pune, India Capgemini Full timeOur Client is one of the United States' largest insurers, providing a wide range of insurance and financial services products with gross written premium well over US$25 Billion (P&C). They proudly serve more than 10 million U.S. households with more than 19 million individual policies across all 50 states through the efforts of over 48,000 exclusive and...
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Lead Specialist- Enterprise Risk Management
2 weeks ago
Pune, India Quest Business Solution Full timePosition Summary: We are seeking a dynamic and experienced professional for the role of Lead Specialist/Sr Lead Specialist in Enterprise Risk Management. The ideal candidate will be responsible for identifying, assessing, and mitigating risks across the organization. This role involves analyzing risk trends, developing risk management frameworks, creating...
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Lead Specialist- Enterprise Risk Management
1 week ago
Pune, India Quest Business Solution Full timePosition Summary: We are seeking a dynamic and experienced professional for the role of Lead Specialist/Sr Lead Specialist in Enterprise Risk Management. The ideal candidate will be responsible for identifying, assessing, and mitigating risks across the organization. This role involves analyzing risk trends, developing risk management frameworks, creating...
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Manager, Risk Manager, Risk
3 weeks ago
Noida, Pune, India Mufg Pension Market Services Full timeJob Description Key Accountabilities and Main Responsibilities Strategic Focus - Implement risk management frameworks, policies, standards, and procedures tailored to the business in alignment with Group-level policies. - Work collaboratively with the business to build and embed a strong risk culture, promoting the Risk as a Mindset approach. - Identify,...
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Operational Risk Specialist
1 week ago
Pune, India Poonawalla Fincorp Full timeAs the Operational Risk Specialist in a Non-Banking Financial Company (NBFC), your primary responsibility is to identify, assess, and mitigate operational risks that could impact the company's operations and reputation. You will play a vital role in enhancing the operational risk management framework and ensuring compliance with relevant regulations. ...
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Operational Risk Specialist
1 week ago
Pune, India Poonawalla Fincorp Full timeAs the Operational Risk Specialist in a Non-Banking Financial Company (NBFC), your primary responsibility is to identify, assess, and mitigate operational risks that could impact the company's operations and reputation. You will play a vital role in enhancing the operational risk management framework and ensuring compliance with relevant regulations....
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Operational Risk Specialist
1 week ago
Pune, India Poonawalla Fincorp Full timeAs the Operational Risk Specialist in a Non-Banking Financial Company (NBFC), your primary responsibility is to identify, assess, and mitigate operational risks that could impact the company's operations and reputation. You will play a vital role in enhancing the operational risk management framework and ensuring compliance with relevant...
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Operational Risk Specialist
1 week ago
Pune, India Poonawalla Fincorp Full timeAs the Operational Risk Specialist in a Non-Banking Financial Company (NBFC), your primary responsibility is to identify, assess, and mitigate operational risks that could impact the company's operations and reputation. You will play a vital role in enhancing the operational risk management framework and ensuring compliance with relevant...
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Operational Risk Specialist
1 week ago
Pune, India Poonawalla Fincorp Full timeAs the Operational Risk Specialist in a Non-Banking Financial Company (NBFC), your primary responsibility is to identify, assess, and mitigate operational risks that could impact the company's operations and reputation. You will play a vital role in enhancing the operational risk management framework and ensuring compliance with relevant regulations....
