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Senior Quality and Regulatory Engineer Healthcubed

3.0 - 5.0 years

4 - 7 Lacs

bengaluru

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Job Description: Senior Quality and Regulatory Engineer Position Overview The Senior Quality and Regulatory Engineer will play a critical role in ensuring that medical devices meet global regulatory requirements and adhere to the highest standards of quality. This position involves leading quality system initiatives, managing regulatory submissions, and supporting product development teams to ensure compliance with ISO, FDA, and other international standards. Key Responsibilities Quality Management Systems (QMS): Maintain and improve QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards. Lead internal audits and support external regulatory inspections. Drive C...

Posted 2 days ago

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