10 Remote fda jobs in Bangalore, India.

... 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 ...

... substantiation dossier and referencing standards - QA junior reviewers' literature selection and reference accuracy Regulatory Compliance - Apply expert knowledge of FDA OPDP, ABPI, EFPIA, and national codes - Identify explicit and implied off-label risks; assess fair balance across text and design - Guide multi-market claim adaptation; ...

... environments. - Experience developing or supporting software products within regulated industries and familiarity with regulatory and compliance requirements, including FDA, IVDR, GxP, HIPAA, or similar frameworks. Technical Skills & Experience - Strong software engineering background with hands-on experience developing enterprise ...

... proofreading skills, and the ability to communicate scientific concepts to diverse audiences. - Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications, and experience in interacting with regulatory agencies during the review ...

... others in a multidisciplinary setting Mastery of SAS and clinical biostatistics - Broad understanding of the drug development process - Conversant knowledge of FDA and other Regulatory guidance and regulations Capable of managing change and uncertainty to optimize positive outcomes Capable of multitasking and sharp attention ...

... pharmaceutical or biotechnology industry. - Advanced Proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA). - Excellent analytical and problem-solving skills with a keen attention to detail. - Excellent communication and collaboration abilities to work effectively ...

... helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years. We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based ...

... service teams to improve product usability. 5. Gather customer feedback and relay it to the product development team. 6. Ensure compliance with medical standards (FDA/CE/ISO) during deployments. 7. Maintain documentation of service reports, training sessions, and issue resolutions. Skill(s) required Biology Business Development ...