120 fda jobs in India.

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, ...

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

... compliance of discipline, cGMP and 5S in the work areas. Should have command on statistical analysis and visualization software like MINITAB, JMP, Power BI etc. Should have knowledge on pharmaceutical quality guidelines ICH, EU and US-FDA, pharmaceutical quality management system, upstream and downstream processing etc.

... Identify nonconformances and support root cause analysis. Ensure inspection equipment calibration and proper handling. Maintain compliance with ISO 13485 and FDA 21 CFR 820 requirements. Qualifications - Diploma/Bachelor's degree in Engineering, Mechanical or related field. - 2–4 years' experience in quality inspection ...

... 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 ...

... 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 ...

• Contract

... 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, ...

• Hybrid
• Full-time

... 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 ...

• Hybrid
• On-site

... 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 ...

As a Forward Deployed Accountant (FDA), you’ll lead the deployment of FloQast’s Transform AI Agents for corporate customers, helping them automate core accounting workflows and improve operational efficiency. You’ll work directly with customers to understand their processes, configure automation solutions, and deliver tangible ...

• Contract

... including central clinical files, Trial Master File (TMF), and clinical trial registry submissions. - Ensure inspection readiness and compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements. Required Skills and Experience - Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related ...

... compliance requirements across pharmaceutical manufacturing operations. Preferred Skills Hands-on exposure to regulatory inspections, audits, and compliance requirements of agencies such as US FDA, MHRA, EU GMP, WHO GMP, and other global regulatory authorities. Experience in remediation and compliance improvement programs.

• On-site
• Full-time

... 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 ...

• Contract

... 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 ...

• Remote
• Hybrid
• On-site

$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 ...

• Remote
• Hybrid
• On-site

... 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 ...

• Remote
• Hybrid
• On-site

... documentation, including protocols, reports, and standard operating procedures (SOPs). - Ensure all CQV activities comply with relevant regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ISPE, ASTM). - Coordinate with cross-functional teams to ensure seamless project execution. - Provide regular project updates ...

• Hybrid
• On-site
• Full-time

... 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 ...

• Contract

675k

... experience in drafting and reviewing narratives. • Should be a Postgraduate (Masters /Mpharm ) or bachelor’s degree. • Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. • Demonstrated high degree of independence with effective presentation, proofreading, ...

• On-site
• Full-time

... 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 ...