197 fda jobs in India.

... globally distributed New Product Development (NPD) teams within regulated industries, preferably medical devices or healthcare technology. - Strong knowledge of FDA Design Controls, ISO 13485 (Medical Devices Quality Management Systems), ISO 14971 (Medical Device Risk Management), IEC 60601 (Medical Electrical Equipment Safety), ...

... equivalent; advanced certification (PgMP or similar) a plus. - Certifications or extensive hands-on experience in CQV; strong CSV expertise; deep familiarity with FDA 21 CFR Part 11, EU Annex 11, and related regulatory frameworks. - Extensive experience delivering validated environments: GMP/GLP labs, ISO 14644 cleanrooms, ...

... computerized systems in an audit-ready state, acting as the primary Automation Subject Matter Expert (SME) during internal audits and regulatory agency inspections (FDA, EMA, etc.). 5. Deviation & CAPA Resolution · Lead complex technical investigations for automation-related deviations and process upsets. · Use systematic root-cause ...

... Argus Safety and external applications using APIs, web services, and interface technologies. - Ensure migrated data and system configurations comply with GxP, FDA 21 CFR Part 11, EMA, ICH E2B(R3), GAMP 5, and organizational validation standards. - Prepare and maintain migration documentation including Migration Plans, Data ...

... Principal Product Security Engineer to lead vulnerability management and SBOM generation for medical devices. The role involves triaging vulnerabilities, ensuring FDA compliance, and automating security processes across product portfolios. Responsibilities - Lead and manage a team of engineers focused on product security and ...

... cross-functional collaboration within the India Development Center in Bangalore. Responsibilities - Drive QA activities in design and development projects, ensuring FDA, ISO, and global regulatory compliance - Advise on design control elements including risk management, usability, and software lifecycle processes - Evaluate and ...

... results and assist in investigations - Calibrate, operate, and maintain laboratory instruments - Ensure compliance with GMP, GLP, SOPs, and regulatory guidelines (FDA, ISO, etc.) - Support method validation, verification, and transfer activities - Assist in stability studies and environmental monitoring (if applicable) - Follow ...

... cybersecurity experience. - Understanding of mitigating security controls, vulnerability management, penetration testing, and code security. - Knowledge of HIPAA, FDA, ISO 27001/2, NIST CSF, and OWASP frameworks. - Understanding of network infrastructure, including firewalls, web proxies, and email architecture. - Experience ...

... university or college - Minimum 5+ years of relevant quality assurance experience - Knowledge of ISO 13485, ISO 14971, and IEC 62304 standards - Understanding of FDA 21 CFR 820 and medical device regulations - Awareness of software development methodologies and computer system validation - Strong oral and written communication ...

... pharmaceutical or healthcare - Proficiency with medical indexing systems (MeSH, Emtree) and Boolean logic - Knowledge of pharmacovigilance principles and regulatory frameworks (EMA, FDA, ICH) - Strong attention to detail and ability to manage multiple priorities under deadlines - Excellent written and verbal communication skills []

... field - 3+ years of document control or quality systems experience in regulated industry - Hands-on experience with Electronic Document Management Systems (EDMS) - Knowledge of FDA 21 CFR Part 11 and 21 CFR Part 820 regulations - Familiarity with ISO 9001 or ISO 13485 standards - Proficiency with Microsoft Office Suite []

... field - 3+ years of document control or quality systems experience in regulated industry - Hands-on experience with Electronic Document Management Systems (EDMS) - Knowledge of FDA 21 CFR Part 11 and 21 CFR Part 820 regulations - Familiarity with ISO 9001 or ISO 13485 standards - Proficiency with Microsoft Office Suite []

... programmers to develop tools supporting CDISC implementation - Lead implementation of productivity tools to improve compliance and efficiency - Ensure deliverables meet FDA guidance and regulatory submission requirements - Monitor regulatory and standards organization updates and communicate changes to leadership Requirements - Bachelor's ...

... equipment validation for sterile dosage forms - Hands-on experience with visual inspection and packing automation technologies - Knowledge of validation concepts and FDA/PDA guidelines - Ability to develop validation protocols and perform gap/risk assessments - Experience with process development or injectable formulation manufacturing ...

Masimo, a Danaher operating company, seeks an engineer to lead computer system validation activities ensuring GxP-regulated systems comply with FDA, ISO, and global regulatory standards. The role involves developing CSV strategies, overseeing validation of enterprise and manufacturing systems, and maintaining compliance ...

... experience with ICF, DCGI, import/export, and EC/IRB submissions - Experience negotiating site contracts and engaging with regulatory authorities - Based in Mumbai or nearby location - Strong ICH GCP, FDA guidelines, and clinical monitoring process knowledge - Leadership, planning, interpersonal, and financial acumen skills []

... with requirements management and configuration management tools - Experience documenting and maintaining design control artifacts in regulated environments - Knowledge of medical device testing and regulated product development (preferred) - Familiarity with FDA regulations and ISO medical device standards (preferred) []

... Demonstrated expertise in ISO 13485 quality management systems - Strong knowledge of medical device change management and standards processes - Understanding of FDA 21 CFR Part 820 and GDP requirements - Analytical and problem-solving abilities with attention to detail [{"name": "hybrid_working", "text": "Hybrid work", "categoryName": ...

... Demonstrated failure investigation and root cause analysis capability - Manufacturing operations and process implementation support experience - ISO 13485 competency - FDA regulated environment and contract manufacturer product transfer experience - NPI and Design Control process experience [{"name": "full_time", "text": "Full time", ...

... PV Operations, Medical Affairs, Regulatory, Quality, and technical teams - Drive compliance with global regulatory frameworks including ICH E2B(R3), EMA EVMPD, FDA, and GVP modules Requirements - Bachelor's degree in Life Sciences, Pharmacy, Nursing, or Health Informatics; Master's preferred - 3–5 years of experience in ...