3 Iso 10993 Jobs

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4.0 - 8.0 years

6 - 16 Lacs

mysuru

Work from Office

Job Description of Biocompatibility/Toxicological Risk Assessment/Chemical Analyst- Senior Engineer or Tech lead 1. Develop and prepare a biological evaluation plan and report. 2. Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard. 3. Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met. 4. Participate in the analysis of technical issues and in the development of recommendations for project decisions and actions. 5. Good Knowledge in of EU MDR 2017/745, ISO 13485, and ISO 14971. 6. Well Exposure in Chemical and material characteriza...

Posted 2 weeks ago

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10.0 - 15.0 years

0 Lacs

pune, maharashtra, india

On-site

Job Title Norm Compliance Officer Job Description Norm Compliance Officer The purpose of this position is to handle end-to-end Norm Compliance activities for Diagnostic X-ray systems as part of the Research and Development team, with all relevant mandatory international and national regulations. Your role: Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations. Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual sy...

Posted 1 month ago

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10.0 - 12.0 years

0 Lacs

mumbai, maharashtra, india

On-site

Job Title: Senior R&D Engineer Medical Devices Location: Mumbai, IND Employment type: Part-time Position Summary: We are seeking an experienced R&D Engineer Trainer with 10+ years in the medical device industry to lead the design, development, and optimization of innovative medical technologies. The role involves driving new product development (NPD) from concept through commercialization, ensuring compliance with global regulatory standards, and collaborating cross-functionally to deliver safe, effective, and high-quality medical devices that improve patient outcomes. Key Responsibilities: Lead the design and development of new medical devices, from feasibility studies through product launc...

Posted 2 months ago

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