Masters degree in Regulatory Affairs or Regulatory Science, Life Science Biology, Microbiology, Chemistry, Medical Technology, Biomedical Engineering, Engineering, or any related field of study, plus at least three 3 years of experience in the job offered or in any related positions.br br In lieu of the abovestated primary education and experience requirements, the company will accept a Bachelors degree in Regulatory Affairs or Regulatory Science, Life Science Biology, Microbiology, Chemistry, Medical Technology, Biomedical Engineering, Engineering, or any related field of study, plus at least five 5 years of postdegree, progressively responsible experience in any related positionsbr br Qualified applicants must also have demonstrable proficiency, skill, experience, and knowledge with the followingbr br 1. Demonstrated experience in regulatory affairs in the medical device industry supporting domestic or international markets.br 2. Demonstrated experience authoring and submitting regulatory submissions including 510ks andor CE Technical Files.br 3. Preparing responses and communicating with regulatory agencies.br 4. Demonstrated understanding of the current regulatory environment and experience performing within it.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 br No travel required. Work from home benefit available
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