Masters degree in Biomedical Engineering, Diagnostic Engineering, Medical Science, Regulatory Affairs or Regulatory Science, Medical Technology, 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 candidates must also have demonstrable knowledge, experience, skill, and proficiency gained through education or employment with the followingbr br 1.Demonstrated experience in the medical device industry.br 2.Demonstrated experience with Good Clinical Practices, Good Manufacturing Practices and FDA regulations.br 3.Demonstrated experience with Quality System Regulations and ISO 134852016 or ISO 14971.br 4.Demonstrated experience with EU MDR or EU MDD requirements.br 5.Demonstrated experience developing regulatory strategies and implemented plans for the preparation and submission of regulatory filings for manufactured products.br 6.Demonstrated experience implementing organizational and policy changes related to regulatory matters.br 7.Demonstrated experience managing regulatory activities such as audits, agency inspections, or product recalls.br 8.Demonstrated ability and experience handling multiple projects simultaneously and prioritizing work to meet reporting and other deadlines.br br No travel required. Work from home benefit available.
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