Regulatory Compliance Manager

3 hours ago


faridabad, India beBeeCompliance Full time

Regulatory Compliance ManagerThe primary role involves overseeing the preparation, review, and maintenance of regulatory submissions and product registrations to ensure adherence to relevant standards.Key Responsibilities:Compile and manage regulatory submissions, encompassing documentation such as Device Master Files and Technical Files.Ensure compliance with international regulations including ISO 13485, EU MDR 2017/745, US FDA 21 CFR Part 820, and local guidelines.Verify labeling, Instructions for Use (IFUs), and promotional materials for regulatory compliance.Oversee product registration, renewals, and post-market submissions to meet regulatory requirements.Maintain awareness of updates and changes in medical device regulations.Support internal and external audits by providing necessary documentation and expertise.



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