Regulatory Affairs Specialist II

Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products In conjunction with Clinical Research, support the preparation of applications (i.e., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia and EU countries Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals Support product registrations for international markets as required. Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects Other duties as assigned Bachelor's Degree or equivalent work experience A minimum of 3 years' work experience in regulatory affairs or related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) Prior experience with class III Medical Devices Knowledge and experience with U.S. FDA, EU, and/or international regulations and standards Minimum of 3 years' experience with Post Market Assessment Interpersonal, communication and negotiating skills. Effective written and oral communication, technical writing and editing skills Works well in fast-paced cross-functional team environments RA certification (by Regulatory Affairs Professional Society)