Ensures regulatory compliance by completing thorough assessments and completing the appropriate submissions pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory bodies. Viewed as team regulatory resource.
• Usually works with minimum supervision having some latitude for independent action or decision, conferring with more senior and supervisory staff when indicated, and keeps supervisor regularly informed on status of work
• Developing and applying basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, legislation, processes and procedures
• Project management, writing, coordination, and execution of regulatory items
• Completing technical and scientific regulatory assignments that are broad in nature
• Usually works with minimum supervision, conferring with superior on unusual matters.
• Usually handles assignments broad in nature, requiring originality and ingenuity.
• 2-3 years of experience in a FDA regulated industry
• Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
• Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of.