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)
Upon completion of waiting period associates are eligible for:
? Medical and Prescription Drug Plans
? Dental Plan
? Supplemental Life Insurance
? Short Term Disability Insurance
? 401(k)
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