Compliance Resource Support
Job Description
Job Requirements
• Knowledge on Safety & EMC standards (IEC 60601 series) pertaining to medical device for global market.
• Knowledge of Medical device regulation (CE Marking), FDA Regulations or other applicable regulatory requirements. Experience in CE certification, FDA etc is preferred.
• Experience on testing of medical devices to IEC 60601-1 series standards . Working knowledge of EMC and safety certification is a plus.
• Preparation of standards test reports and other documentation in accordance with applicable regulations.
• Experience in product development life cycle process ( change control, DHF, test reports, documentation etc)
• Medical device System engineering knowledge- preferred
• Preparation of the product compliance DHF documentation.
• Knowledge of Quality Management system.
• Self-motivated with good interpersonal skills
Strong analytical and problem-solving skills.
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Job Detail
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Job IdJD3519174
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IndustryNot mentioned
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Total Positions1
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Job Type:Contract
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationKA, IN, India
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EducationNot mentioned
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ExperienceYear