57 fda jobs in Bangalore, India.

... to support software validation activities for molecular diagnostic systems. The role involves design control, risk management, and regulatory compliance under FDA and ISO standards, reporting to the Associate QA Manager in Bengaluru on an onsite basis. Responsibilities - Plan, execute, and document validation activities ...

... and enterprise applications - Proven success managing IT projects and leading digital transformation initiatives - Experience in regulated environments (GxP, FDA) with compliance knowledge - Advanced knowledge of ITIL processes, IT security, and risk management - Demonstrated ability to lead distributed teams and manage ...

... 10 years professional experience in product development - 8+ years leading manual and automated testing activities - Experience with medical device testing and FDA/CE Mark regulations - Knowledge of test management tools (ALM, JAMA, Microsoft Project, Rally) - Proficiency with UFT, Python, or C# scripting - Understanding ...

... challenges and drive optimal technology solutions. - Support Usability Engineering and Human Factors activities, ensuring compliance with IEC 62366 and relevant FDA guidance. - Apply reliability and robustness engineering principles to enhance product performance, quality, and customer experience. - Develop high-quality technical ...

... Life Sciences - Proficiency with PLM platforms such as Teamcenter, Windchill, or Agile PLM and SAP - Strong analytical, problem-solving, and stakeholder management capabilities - Knowledge of FDA 21 CFR Part 11, 820, 809 and ISO 13485 compliance requirements - Familiarity with GMP, GDP, and Change Control processes []

... engineering, nursing, or related discipline - Strong medical device industry background; pharmaceutical experience also considered - Demonstrated knowledge of ISO, FDA, and international regulatory requirements - Experience leading regulated global clinical trials highly preferred - Cross-functional leadership and team-building ...

... programming language proficiency - Minimum 8 years industry experience in clinical data management and standards - Advanced proficiency in CDISC standards and FDA/EMA regulations - Statistical programming background focused on SDTM tasks - Demonstrated leadership skills and cross-functional collaboration ability - Willingness ...

... concept to market - Expert-level knowledge in diagnostics, biologics, or instrumentation domains - Strong understanding of quality systems, regulatory frameworks (FDA, ISO, GMP) - Demonstrated ability to build, mentor, and manage scientific and technical teams - Strategic business acumen with project management and budget oversight ...

... design transfer activities - Minimum 3 years demonstrating project leadership skills - Willingness to travel to global manufacturing locations up to 20% of the time - Experience with ultrasound probe or transducer design and manufacturing preferred - Knowledge of ISO, FDA, and regulatory standards strongly preferred []

... certificate management - Proven experience designing DevSecOps and Security-as-Code with CI/CD integration tools - Medical-device cybersecurity knowledge including FDA expectations, IEC standards, and NIST SSDF - Strong threat modeling and security architecture skills using STRIDE and attack-surface analysis - Bachelor's degree ...

... electro-mechanical product development focus - Experience developing complex products in regulated industries, preferably medical devices - Working knowledge of FDA regulations, Medical Device Regulation (MDR), and quality standards - Experience with requirements management tools such as DOORS or Polarion - Familiarity with ...

... - Author and review design control and risk management documentation throughout development process Requirements - Knowledge of medical electrical standards, FDA QSR, EU MDR, and regulatory requirements - Product design and development experience, preferably in medical devices or orthopaedic implants - Proficiency with ...

... medical devices - Hands-on experience with SaMD, Embedded Software, Connected Devices, or Robotics Software - Strong knowledge of IEC 62304, ISO 13485, ISO 14971, FDA Design Controls, and software lifecycle compliance - Experience with Agile methodologies and tools such as Jira or Azure DevOps - Understanding of Medical Device ...

... experience across software, hardware, and systems - Expertise in writing V&V plans, procedures, test execution, and report generation at multiple levels - Knowledge of FDA, ISO, and IEC design control procedures and medical device regulations - Experience with electro-mechanical, electrical, and software testing methodologies and ...

... Five or more years of Agile development and test development experience is also stated in the posting. - Medical device industry experience and familiarity with FDA design control processes are highly desired. - Familiarity with Airflow, Dataflow, BigQuery, Kafka, performance testing, and cloud-based CI/CD is preferred. Benefits ...

... Engineering, Industrial Engineering or related field - Experience, practitioner in basic engineering function of medical device - Experience in Medical development, FDA Regulations and MDR. - Strong interpersonal skills with the ability to collaborate with others in a team environment - Understanding of and adherence to FDA, ...

... enterprise applications • Demonstrated success managing IT projects and leading digital transformation initiatives • Experience working in regulated environments (GxP, FDA, etc.) and ensuring compliance • Advanced knowledge of ITIL processes, IT security best practices, and risk management • Excellent stakeholder management and ...

... expertise in relevant technical domains (e.g., diagnostics, biologics, instrumentation) • Strong understanding of quality systems and regulatory requirements (FDA, ISO, GMP) • Experience managing complex projects, budgets and resources • Strong leadership abilities with demonstrated success building and developing teams ...

... Management Systems (QMS). - Excellent organizational, communication, and problem-solving skills. - Proficiency with Microsoft Office Suite. Preferred Knowledge - FDA 21 CFR Part 11 - 21 CFR Parts 820 - ISO 9001 and/or ISO 13485 - GMP, GDP, Change Control, CAPA, and Risk Management Leadership Responsibilities - Provide day-to-day ...

... considered. - Previous experience with regulated global trials highly preferred. - Demonstrated knowledge and application of clinical requirements, including ISO, FDA, and International requirements. - Demonstrated ability to expand application of clinical and regulatory knowledge to interdivisional projects as needed. - Demonstrated ...