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 1 day ago

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Computer System validation Engineer Sapphire Software Solutions Inc

4.0 - 6.0 years

0 Lacs

india

Remote

HI Folks Please check the JD and share your updated resume to my email [HIDDEN TEXT] and ping me on whatsapp (+91 970-529-6474) along with your resume Computer System validation Engineer 100% Remote 1 year contact REQUIRED SKILLS AND EXPERIENCE -Bachelor's degree or equivalent in a relevant field (Computer Science, Engineering, Life Sciences, Data Science, or similar). -46 years of related experience in computer system validation. -Hands-on experience with CSV in regulated environments such as MedTech or Pharma. -Strong knowledge of regulatory requirements, including: 21 CFR Part 11 ,EU Annex 11, ISO 13485, IEC 82304, FDA CSA, MDSAP

Posted 1 week ago

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