Sr. Regulatory Affairs Specialist
Master’s degree in Regulatory Affairs, Mechanical Engineering or Biomedical Engineering and one year of experience with regulatory affairs in medical device. Must possess a minimum of one year of experience with each of the following: PMA (Pre-Market Approval) and 510(k) submissions for US Class III and Class II medical devices; design dossiers, technical files and change notifications for AIMD and MDD medical devices; promotional material review for US Class III and Class II medical devices; pre- and post-market clinical investigations for Class III and Class II medical devices; writing and training for regulatory SOP (Standard Operating Procedures); total product life-cycle regulatory experience to include pre-clinical, clinical, approval, post-approval and obsolescence; food Drug and Cosmetic Act and relevant Medical Device Regulations to include (21 CFR Parts 11,50,54,56,803,806,807,812,814); and Medical Device Quality Systems and Risk Management to include (21 CFR 820, ISO13485, ISO14971).
