Regulatory Affairs and Quality Assurance Specialist (Post Market) jobs in United States
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Kelly Science, Engineering, Technology & Telecom · 3 days ago

Regulatory Affairs and Quality Assurance Specialist (Post Market)

Kelly Science, Engineering, Technology & Telecom is seeking a Regulatory Affairs and Quality Assurance Specialist for an entry-level position. The role involves ensuring regulatory compliance through assessments and submissions related to product clearances and approvals by various regulatory bodies, while also managing regulatory projects and assignments.

Staffing & Recruiting
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Hiring Manager
Deanna Saulsbury
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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

FDA regulationsRegulatory submissionsRAC certificationProject managementScientific knowledgeTechnical writingCommunication skills

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. Sponsorship is NOT available NOW or in the FUTURE for this role

Preferred

RAC certification or Advanced Degree (Masters in Regulatory Affairs)

Company

Kelly Science, Engineering, Technology & Telecom

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Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.

Funding

Current Stage
Late Stage

Leadership Team

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Linda Stuit
Senior Vice President, Engineering Specialty
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Company data provided by crunchbase