Search current fda jobs, vacancies, and employment in Bengaluru, India on Jobeax. 26 fda jobs in Bengaluru, India.
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... Translate user needs, clinical requirements, and business objectives into system requirements and technical specifications. Drive compliance with Design Controls, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, and applicable regulatory standards. Lead system-level risk management activities including ...
India, Bengaluru
BPL Medical Technologies
... balancing electrical, mechanical, and biocompatibility requirements while ensuring designs meet stringent safety and regulatory standards (IEC 60601, ISO 13485, FDA 510(k)/PMA pathways). Lead System Design & Engineering Lead the end-to-end design of external defibrillator electrode/lead systems, including pad electrodes, ...
India, Bengaluru
Vantive Corporation
... corrective/preventive actions to ensure sustained compliance. Regulatory Intelligence Maintain deep knowledge of India local requirements (e.g., CDSCO, State FDA, CBN, DSIR) and relevant global regulatory expectations (e.g. pharmacopoeial requirements such as EU/US Pharmacopeia expectations where applicable). Provide subject ...
India, Bengaluru
Tricog Health
... steering committees) 3. Healthcare & Regulatory Context ● Ensure project workflows comply with applicable standards such as IEC 62304, ISO 13485, or local MDR/FDA requirements where relevant. 4. Process & Continuous Improvement - Identify and brainstorm process gaps and improvements with the stakeholders. - Conduct structured ...
India, Bengaluru
1k - 4500
... Engineer role focuses on developing, implementing, and maintaining robust quality systems within a regulated environment, with a strong emphasis on ISO standards, FDA Quality System Regulation (QSMR), and risk management. The position supports medical device quality engineering activities, including design control, validation, ...
India, Bengaluru
3G HR Services
Rs 2.5 - 8 lakhs p.a.
... documentation of design/development activities - Understanding of medical devices and human respiration system - Experience in risk management and ISO 14971 is added advantage - Knowledge of FDA regulations and Medical Devices Directive ~93/42/EEC - GDP & GMP Experiences (Good Documentation Practice & Good - Manufacturing practice
India, Bengaluru
... collaborate with cross-functional teams to investigate and resolve them. - Assess complaints to determine reportability to global regulatory authorities (e.g., FDA, EU MDR). - Monitor complaint trends and provide insights for product improvement and safety related field actions. - Provide support for risk management related ...
India, Bengaluru
... compliance to basic requirements, e.g. ISO standards and regulations like Medical Device Regulation (European Union Regulation), Quality system regulation (US FDA) - Assessment of completeness of Design history file and Device master records?- Participate in reviews as per QMS, external and internal audits - Provide process ...
India, Bengaluru
... You'll define and advance quality and compliance strategies for SAP products and cloud services, ensuring alignment with global regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, ICH guidelines, and GAMP 5. Your expertise will help SAP and its customers confidently adopt innovative technologies while maintaining ...
India, Bengaluru
Infinite Computer Solutions India Pvt. Ltd.
... Reports - FBDI templates, SOAP/REST APIs - OIC or other integration platforms - Understanding of healthcare-specific SCM workflows and regulations (e.g., HIPAA, FDA device tracking). Preferred Qualifications: Experience integrating Oracle with EPIC/Cerner, GHX, or McKesson systems Familiarity with GS1 standards, UDI compliance, ...
India, Bengaluru
Zimmer Biomet
... foundation models, when to fine-tune, and when to build custom models. Define and enforce AI architecture principles, security policies, and compliance (HIPAA, FDA, ISO). Implement guardrails for privacy, PHI/PII protection, safe model usage, hallucination risk mitigation, audit logging, and explainability Partner with data ...
India, Bengaluru
... requirements are incorporated into product design, development, verification, validation, and post-market activities. Support regulatory activities associated with FDA, EU MDR, UK MDR, UKCA, MHRA, Health Canada, MDSAP, and other applicable global regulatory frameworks. Author and maintain regulatory documentation including technical ...
India, Bengaluru
... strategies, contract management, and quoting processes specific to healthcare products/services. Ensure compliance with healthcare regulations and standards (e.g., FDA, MDR, HIPAA where applicable). Troubleshoot, debug, and optimize existing CPQ implementations. Participate in testing (unit, integration, UAT) and deployment ...
India, Bengaluru
NTT DATA Services
$30 USD
... traceability matrices. - Strong knowledge of defect management, test evidence, and validation documentation controls. - Familiarity with regulatory expectations such as FDA 21 CFR Part 11, EU Annex 11, and data integrity principles. - Experience using test management and defect-tracking tools such as ALM, Jira, Azure DevOps, or similar ...
India, Bengaluru
Danaher
... Experience in medical device design & development in Agile environment is a plus. Understanding of software development processes for a regulated environment (FDA/ISO13485) and experience in medical device verification is a plus Whether it's a health care program or paid time off, our programs contribute to life beyond ...
India, Bengaluru
... subtractive machining, anodization, additive manufacturing, forging, casting, plastic molding) and material science for application in new product development desired - FDA QSR and EU MDR medical device regulatory requirements, and industry/regulatory body recognized technical product standards knowledge desired - Statistics knowledge ...
India, Bengaluru
... requirements are incorporated into product design, development, verification, validation, and post-market activities. - Support regulatory activities associated with FDA, EU MDR, UK MDR, UKCA, MHRA, Health Canada, MDSAP, and other applicable global regulatory frameworks. - Author and maintain regulatory documentation including ...
India, Bengaluru
Ge Healthcare
... DEPS or equivalent product cybersecurity lifecycle processes in regulated industries. - Understanding of applicable cybersecurity and privacy frameworks such as FDA cybersecurity guidance, NIST, ISO 27001, IEC 81001-5-1, HIPAA, GDPR, SOC 2, or similar standards. - Experience assessing third-party products, SaaS services, ...
India, Bengaluru
... Data Manager or equivalent combination of education, training, and experience • Skills: · Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance · Experience in clinical trial databases and applications, clinical data flow, data review, and eCRF Report Form ...
India, Bengaluru
... AWS. You have experience with containerization tools such as Docker and Kubernetes. You may have experience in the medical device industry and familiarity with FDA design control processes (highly desired). Your knowledge of GCP tools like Airflow, Dataflow, and BigQuery is a plus. Experience with distributed event streaming ...
India, Bengaluru