Regulatory Affairs and Quality Assurance Specialist

Work Authorization

Must be currently in the United States with active employment authorization documents without CURRENT sponsorship transfer requirements. Sponsorship is NOT available NOW or in the FUTURE for this role.

Pay: Negotiable depending on direct-related experience up to $48 - $58 an hour

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

To be immediately considered, please send an updated version of your resume to

*** (Kelly does not expense relocation/interview costs)***