Sr. Regulatory Affairs Analyst jobs in United States
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iMPact Business Group · 5 hours ago

Sr. Regulatory Affairs Analyst

positionUnited States
timeContract
remoteRemote
seniorityMid, Senior Level
money$60/hr - $63/hr
date2+ years exp

iMPact Business Group is seeking a Sr. Regulatory Affairs Analyst for a 12-month contract with a client in the Medical Device Industry. The role involves ensuring regulatory compliance through assessments and submissions for product clearances/approvals by various regulatory bodies.

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Growth OpportunitiesbadNo H1Bnote

Responsibilities

Ensuring regulatory compliance by completing thorough assessments and submitting appropriate documentation pertaining to product clearances/approvals by FDA, Notified Bodies, and other regulatory agencies
Working with minimum supervision, exercising some autonomy for independent actions or decisions, conferring with senior and supervisory staff when needed, and keeping supervisors regularly informed on work status
Developing and applying fundamental knowledge and understanding of regulatory and legal frameworks, requirements, legislation, processes, and procedures
Managing projects, writing, coordinating, and executing regulatory items
Completing technical and scientific regulatory assignments that are broad in scope
Working with minimal supervision, consulting with superiors on unusual matters
Handling broad, complex assignments that require originality and ingenuity

Qualification

Regulatory complianceRegulatory submissionsRAC certificationHealthcare industry experienceLife sciences experienceLanguage skillsGlobal market regulationsProject managementTechnical writing

Required

Bachelor's degree (B.S. or B.A.) in Engineering, Science, or related fields
2-3 years of hands-on experience in regulatory compliance within the healthcare or life sciences industry
RAC (Regulatory Affairs Certification) or Advanced Degree such as a Master's in Regulatory Affairs
Previous experience working on regulatory submissions with Notified Bodies or other international agencies

Preferred

Additional language skills or familiarity with global market regulations

Company

iMPact Business Group

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iMPact Business Group provides staffing solutions in the IT, accounting, finance, engineering, and business process industries.
dateFounded in 2004
location
Grand Rapids, Michigan, USA
people-size51-200 employees
web-link
https://www.impactbusinessgroup.com/

Funding

Current Stage
Growth Stage

Recent News

PRLog
iMPact Business Group Fills Critical Manufacturing Roles in Muskegon, MI, in Under One Week
2025-11-07
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