EducationExperience Requirement Masters degree Regulatory Science or Affairs, a Life Science, Business Administration or Marketing, or a related field and 3 years of experience as Quality Specialist or Manager, Regulatory Specialist or Manager, or related position in the medical device area.br br Alternatively, Bachelors degree in Regulatory Science or Affairs, a Life Science, Business Administration or Marketing, or a related field and 5 years of progressive postbaccalaureate experience as Quality Specialist or Manager, Regulatory Specialist or Manager, or related position in the medical device area.br br Specialized Experience 3 years experience supporting global medical device registration in compliance with Global Medical Device Regulations; 3 years of experience with U.S. regulatory submissions in compliance with 21 CFR Medical Device Regulations; 3 of years experience with supporting product development projects with regulatory strategies and guidance; 1 year of analyzing and resolving complex regulatory submission issues.br br Telecommuting permitted up to 3 days per week.br br 10 Travel, international and domestic, fully reimbursed.
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