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Job #03441

About our client Our client is a young venture-backed medical device company headquartered in Southern California that is focused on the development and commercialization of innovative drug delivery and surgical wound care products. The company has an experienced management team, strong financing and a robust pipeline of products in development with excellent momentum. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory Affairs Manager Irvine CA - South Salary Highly competitive package, commensurate with experience Responsibilities 1) Regulatory submissions for company products in both the US and International markets 2) Responsible for developing Regulatory approval strategies based upon company priorities 3) Responsible for preparing all types of regulatory submissions (e.g. IDE’s, 510(k)’s, PMA’s, PMA supplements and CE Design Dossier’s) 4) Responsible for reviewing product complaints and filing MDR and vigilance reports as needed 5) Responsible for communicating with Regulatory agencies 6) Responsible for Reviewing all product labeling 7) Responsible for participating as the regulatory representative in new product development teams Requirements 1) BA/BS in a scientific discipline or an equivalent combination of education and experience 2) Minimum 5 Years experience in Regulatory Affairs 3) Must have experience in preparing submission for Class III Medical Devices 4) Experience should include PMA submissions and CE Design Dossiers 5) Previous practical experience with clinical research studies in cardiovascular medical device applications or equivalent nursing experience is preferred 6) Proficiency in MS Word and Excel required