IntePros is currently looking for a Regulatory Affairs Specialist to join one of our growing Medical Device clients in Audubon, PA. The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with internal teams while following FDA 21 CFR regulations.
Regulatory Affairs Specialist Job Responsibilities:
Regulatory Affairs Specialist Qualifications:
...Certifications: Must possess one of the following 8140 IAT Level II or III baseline certifications: Level II certs include - CCNA Security, GISCP, GSEC, Security+ CE, SSCP Level III certs include - CASP CE, CCNP Security, CISA, CISSP (or Associate), GCED,...
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