5 Fda Guidance Jobs

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10.0 - 12.0 years

0 Lacs

chennai, tamil nadu, india

On-site

Job Description Required Qualifications: Licensed clinician (RN, PharmD, MD, NP, PA, or equivalent) with 10+ years of clinical experience. Minimum 10+ years experience in product management, clinical informatics, or usability/human factors engineering within healthcare technology or medical devices. Knowledge of ISO 14971, IEC 62366, EU MDR/IVDR, and FDA guidance related to medical device software (SaMD). Strong understanding of clinical risk, safety analysis, and usability validation methodologies. Proven ability to translate complex clinical workflows into clear design and engineering requirements. Excellent cross-functional communication and documentation skills. Preferred: Experience sup...

Posted 1 week ago

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0.0 years

0 Lacs

bengaluru, karnataka, india

On-site

Job Description: The Enterprise Architect for Medical Device Software is a senior individual contributor responsible for defining and governing the software architecture and compliance framework for regulated medical devices. This role bridges product development, regulatory, and enterprise architecture functions - ensuring that device software solutions are designed securely, maintain regulatory compliance, and align with enterprise standards and long-term technology strategy. You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA guidance), define software interfaces, manage traceability across the system lifecycle, and s...

Posted 3 weeks ago

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12.0 - 16.0 years

0 Lacs

karnataka

On-site

As a Usability Designer at Philips, your role involves focusing on ensuring that Emergency Care products and solutions are safe, effective, efficient, intuitive, and satisfactory to use. You will be responsible for raising awareness of usability and user-centered design, advocating for user needs and patient safety in the Emergency Care business and project teams. Key responsibilities include: - Defining the usability strategy and leading usability activities in collaboration with a multi-disciplinary team - Conducting user research, task analysis, and creating use scenarios - Creating the usability engineering plan and analyzing post-market data to identify usability issues - Leading the us...

Posted 2 months ago

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5.0 - 7.0 years

0 Lacs

pune, maharashtra, india

On-site

Job Description Help shape the future of healthcare by designing safe and intuitive image guided surgery and diagnostic imaging systems. As a Usability Designer, you will apply human factors and usability expertise to ensure Philips IGT products meet user needs and regulatory requirementsenabling clinicians to deliver faster, more effective care. Your role: Make a greater impact by improving the safety, usability, and effectiveness of our IGT systems, directly supporting better outcomes for patients and caregivers. Collaborate with cross-functional teamsincluding engineering, clinical, marketing, quality, regulatory, and serviceto deliver human-centered solutions that meet global medical dev...

Posted 2 months ago

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10.0 - 12.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Be the First to Apply Job Description Essential Duties and Responsibilities Coordinates batch documentation review with operations groups to ensure GMP compliance and timely delivery of products to customers Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements Supervises day-to-day functions of the QA Operations team Mentors/coaches and provides succession planning for direct reports Ensures all production and QC documentation has been reviewed prior to disposition If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they ha...

Posted 3 months ago

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