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Job #03224

About our client Our client is a rapidly growing biotech company that focuses on wound care and infection control therapeutics. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of it's employees. Position Location Regulatory Affairs Manager Beaverton, Oregon Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee implementation of international and domestic regulatory strategies 2) Prepare 510(k)s, PMA and IDE submission applications 3) Research current domestic and international regulatory requirements 4) Prepare design dossiers for review by notified body 5) Submit product registrations and applications to foreign governments as required, i.e. TGA and DOH 6) Review and approve product changes in accordance with regulatory guidelines Requirements 1) BS in a related field (advanced degree preferred) 2) Minimum 5 years of experience in regulatory/clinical affairs 3) Experience and expertise in PMA, 510(k) and IDE submissions 4) Medical device background 5) Management/supervisory experience