Regulatory Affairs Specialist II

• Support the IVDR project by revising the assigned technical files
• Support the IVDR labeling conversion project
• Support the tasks to un-CE Mark selected products and track the work
• Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator

• Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields
• 3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry
• Able to work independently and with others
• Communication skills, including negotiation and persuasion
• Analytical, problem solving, computer, and critical thinking skills
• Thorough knowledge of policies, practices and procedures related to RA

Knowledge of FDA, and CE marking requirements for IVD products is a plus