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SRE (Safety & Regulatory Engineer)

12.00 to 15.00 Years   Bangalore   27 Apr, 2020
Opto Circuits (India) Ltd
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaGeneral / Other SoftwareSales / BD
EmploymentTypeFull-time

Job Description

Job Description

  • Must have a work experience in IEC 60601-1 (and associated collateral standards).The position will participate in the development of product specifications, ensuring project compliance to internal and external standards, and regulatory compliance, coordinating the risk analysis activities, and creating and managing the quality engineering deliverables.
    • As Safety Regulatory Engineer, devising solutions in product design to meet the regulatory requirements like CE marking, FDA and CMDCAS etc.
    • Ensuring that the design process meets the Regulatory Compliance Plan by reviewing the process throughout the Product Life Cycle.
    • Identifying and incorporating regulatory requirements in the design of new Products and process in coordination with the cross functional teams from India and overseas for medical products
    • Possess a Master/Bachelorrs degree in Engineering
    • Has a minimum of 12 years of medical product development experience.
    • Knowledge and experience with Medical Electronic Standards such as IEC 60601, includesIEC 62304, ISO 14971, 21CFR 820, ISO 13485 etc., Experiencein Class III medical deviceswill be desirable.
,

Keyskills :
design cmdcas iec medical ce marking fda risk iso iii egulatoryrequirements qualityengineering cemarking productdesign iso13485 regulatorycompliance iec60601 iso14971 productdevelopment riskanalysis

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