Kelly Science, Engineering, Technology & Telecom · 6 hours ago
Regulatory Affairs and Quality Assurance Specialist
Kelly Science, Engineering, Technology & Telecom is seeking a Regulatory Affairs and Quality Assurance Specialist. This role ensures regulatory compliance by completing assessments and submissions for product clearances and approvals by various regulatory bodies. The specialist will work independently while collaborating with senior staff as needed.
Responsibilities
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
Qualification
Required
2-3 years of experience in a FDA regulated industry
Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related
Must be currently in the United States with active employment authorization documents without CURRENT sponsorship transfer requirements
Preferred
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.