19 fda jobs in Pune, India.

... development, with deep expertise in Regulatory Affairs and Regulatory information management system. - Strong knowledge of global regulatory frameworks, including FDA, EMA, ICH guidelines, and regional market specific requirements. - Extensive knowledge of global regulatory frameworks, including FDA, EMA, ICH guidelines, and ...

... Release Trains following SAFe framework will be a plus. - Quality mindset, A Six Sigma Green Belt will be a plus. - Experience with Regulatory aspects, Knowledge of FDA guidelines and compliance requirements for medical (ISO13485, FDA) will be preferred. - Translating customer needs into technical requirements and then creating ...

... Qualifications : - Experience in Medical Device, Life Sciences, Pharmaceutical, or regulated manufacturing environments.- ITIL Foundation Certification.- Siemens Opcenter/Camstar implementation or support experience.- Familiarity with FDA 21 CFR Part 11, GxP, and validation-controlled environments. (ref:hirist.tech) []

... a plus. - Experience in user interface (UI) design and knowledge of UX principles for hardware/software integration will be an added advantage. - Knowledge of FDA guidelines and compliance requirements for medical devices will be preferred. How we work together: We believe that we are better together than apart. For our ...

... relevant exposure in actuators, cylinders and valve domain with 8- 14 years - Knowledge about various standards applicable to cylinder product line - NFPA, ISO, FDA etc - Knowledge of elastomers used in cylinders - Good knowledge about cylinder configurations - referencing catalog - Software skills: Creo (Expert level), knows ...

... use of trial management or data management systems. - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. [{"name": "permanent_employment", "text": "Permanent employment", "categoryName": "Type of employment"}, {"name": "full_time", "text": ...

... 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 ...

... 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 ...

... 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 []

... cybersecurity experience. - Strong understanding of mitigating security controls . - Vulnerability Management, Penetration Testing, Code Security. - Good to have - FDA and other medical device regulators experience. Knowledge of cyber security standard frameworks such as HIPAA, FDA, ISO 27001/2, NIST CSF, and OWASP. - Understanding ...

... regulated and business critical computerized systems for global pharmaceutical clients. The ideal candidate will ensure compliance with global regulatory standards (FDA, EMA, MHRA) and drive strategic initiatives for business process transformation and operational excellence. Your Key Responsibilities - Lead CSA/CSV strategy ...

... and analytical skills and high attention to detail; - Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines. [{"name": "permanent_employment", "text": "Permanent employment", "categoryName": "Type of employment"}, {"name": "full_time", "text": ...

... cybersecurity experience. - Strong understanding of mitigating security controls . - Vulnerability Management, Penetration Testing, Code Security. - Good to have - FDA and other medical device regulators experience. Knowledge of cyber security standard frameworks such as HIPAA, FDA, ISO 27001/2, NIST CSF, and OWASP. - Understanding ...

... 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 ...

... solving and organizational skills with the ability to work both independently and in a team environment. - Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

... verbal English communication skills. - Strong organizational and analytical skills with high attention to detail. - Ability to lead within a global team environment, providing guidance to colleagues and ensuring deliverables are met. - Good knowledge of GCP and applicable Health Canada, FDA, and EMA regulations/guidelines.

... pharmaceutical advertising agency environment - Thorough knowledge of current AMA style; experience with medical/regulatory/legal reviews and familiarity with FDA requirements for drug promotion - Demonstrated comfort and confidence with medical/pharma and industry terminology - Extremely detail oriented, thorough and accurate ...

... or pharmaceutical advertising agency environment Thorough knowledge of current AMA style; experience with medical/regulatory/legal reviews and familiarity with FDA requirements for drug promotion Demonstrated comfort and confidence with medical/pharma and industry terminology Extremely detail oriented, thorough and accurate ...

... drug development process, ICH guideline (including but not limited to, ICH E6, E9, and E9(R1)), relevant Health Canada (HC) and Food and Drug Administration (FDA) regulations, guidelines, and electronic data submission requirements, and Pharmaceutical Industry GPP. - Very organized and detail-oriented, with effective project ...