Global Regulatory Affairs Specialist
$60 per hourManpower
Regulatory Affairs Specialist III
Take your regulatory affairs expertise to the next level with an opportunity to support innovative diagnostic products on a global scale. This role offers the chance to work with cross-functional teams, contribute to international regulatory submissions, and play a key role in bringing compliant healthcare solutions to markets around the world.
Location: Irvine, CA (Hybrid) Pay Rate: $55 - $60/hr Employment Type: 6-Month Temporary Assignment (Projected through March 1, 2027) Schedule: Monday-Friday, 8:00 AM-5:00 PM
Why This Role Matters
As a Regulatory Affairs Specialist III, you will help ensure critical diagnostic products meet global regulatory requirements, support product development initiatives, and maintain regulatory compliance across international markets. Your expertise will directly contribute to successful product registrations, labeling compliance, and regulatory strategy execution.
What You'll Do
Manage global regulatory submissions, registrations, renewals, and maintenance activities for new and modified products across international markets
Support new product development initiatives, product modifications, and IVDR implementation projects
Ensure product claims, labeling, Instructions for Use (IFUs), and supporting documentation comply with applicable global regulations
Coordinate responses to regulatory authority inquiries and information requests with cross-functional teams
Manage Regulatory Affairs change requests and maintain audit-ready documentation and records
Maintain technical documentation supporting CE Marking and other applicable regulatory requirements
Coordinate product labeling updates and communicate changes to stakeholders and regional teams
Manage SAP product restrictions to ensure ongoing regulatory compliance
Support special projects and additional Regulatory Affairs activities as assigned
What We're Looking For
A current, up-to-date resume
Bachelor's degree in Biology, Chemistry, Medical Technology, or a related scientific discipline
5+ years of experience in domestic and international regulatory affairs or regulatory compliance, preferably within the IVD industry
Advanced degree and/or Regulatory Affairs Certification (RAC) preferred
Extensive knowledge of global regulatory requirements, including FDA, NPMA, and IVDR regulations
Strong understanding of product labeling requirements and international product registration processes
Detail-oriented with strong technical and regulatory writing skills
Experience using quality management systems and SAP applications
Ability to perform basic statistical analysis
Strong analytical, communication, problem-solving, and critical-thinking skills
Proven ability to manage multiple priorities and deadlines in a fast-paced environment
Strong customer focus with the ability to collaborate with internal and external stakeholders
Ability to meet compliance requirements * Must be eligible and provide proof of eligibility to work in the US
What's In It For You
Competitive pay at $60 per hour
Opportunity to work with an industry leader in life sciences and diagnostics
Hands-on experience supporting global regulatory initiatives and IVDR implementation
Collaborative, cross-functional work environment
Valuable experience with international registrations, CE Marking, and regulatory submissions
Hybrid work arrangement offering flexibility and onsite collaboration
Benefits for Manpower Associates (Upon Eligibility)
Medical and Prescription Drug Plans
Dental Plan
Supplemental Life Insurance
Short Term Disability Insurance
401(k)
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