to determine effective medical device regulatory strategies to comply w/ various worldwide Quality System reqmts.
Prepare FDA submissions, which may incl: Traditional & Special 510(k)s, Premarket Approval (PMA) Supplements & Reports, BLA Supplements & Reports.
Reqs a Bachelor's Deg in Life Sciences, Pharmacology, Biotechnology, Biology, Chemistry, or rltd field, plus 3 yrs of regulatory affairs exp. Will also accept a Master's Deg in Life Sciences, Pharmacology, Biotechnology, Biology, Chemistry, or rltd field, plus 1 yr of regulatory affairs exp. Exp must incl 1 yr of exp w/ each of the following: Analyze & interpret technical documents, professional journals, technical procedures & government regulations; Worldwide medical device registrations & regulated envrmts, including 510(k) & premarket approval (PMA) pathways, Technical Files, Design Dossiers, & Canadian registrations; Assessing whether changes to Class III & Class II devices req regulatory submissions & writing & compiling post-approval submissions; Reviewing device promotional materials & labeling for FDA & regulatory compliance; & Agile & Oracle systems.
Will accept any suitable combo of edu, training, or exp. Apply online
Location/Region: San Diego, CA (US - 92122)