Bachelors degree or higher in Regulatory Affairs or Regulatory Science, Life Science Biology, Microbiology, Chemistry, Medical Technology, Engineering, or any related field of study, plus at least two 2 years of experience in the job offered or in any related positions.br br Qualified applicants must also have demonstrable proficiency, knowledge, skill, and experience with the followingbr br 1. Demonstrated knowledge of Regulatory environment.br 2. Demonstrated knowledge of GMP regulationsbr 3. Demonstrate experience with FDA and EU medical device regulations.br 4. Demonstrate knowledge of International standards applicable to medical devices.br 5. Demonstrated knowledge of FDA regulations and guidelines.br 6. Demonstrated ability to evaluate information to determine compliance with standards, laws, and regulations.br 7. Teams, SharePoint, MS Project, or ComplianceWirebr br No travel required; Work from home benefit available.
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