Global Regulatory Affairs Specialist

ManpowerGroup; Irvine (CA); Hybrid; USD 76,000 - 83,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive pay

Global regulatory initiatives

Job summary

ManpowerGroup seeks a Regulatory Affairs Specialist III to support global regulatory submissions and compliance for innovative diagnostic products. You will work with cross-functional teams to ensure registrations, labeling, and regulatory strategy execution across international markets.

The role focuses on global submissions, IVDR projects, and interaction with regulatory authorities, with a hybrid Irvine, CA work arrangement and a 6-month temporary assignment through March 1, 2027.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Medical Technology, or related scientific discipline.
• 5+ years of experience in domestic and international regulatory affairs or regulatory compliance, preferably within the IVD industry.
• Knowledge of FDA, NPMA, and IVDR regulations.
• Experience with product labeling and international registrations.
• Experience with SAP and quality management systems.
• Strong regulatory writing and analytical skills.
• Eligibility to work in the US.

Responsibilities

• 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 labeling, IFUs, and documentation comply with global regulations.
• Coordinate responses to regulatory authority inquiries with cross-functional teams.
• Manage Regulatory Affairs change requests and maintain audit-ready documentation.
• 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.

Skills

Regulatory knowledge

Regulatory writing

FDA/IVDR regulations

Quality management systems

SAP

Statistical analysis

Analytical skills

Communication skills

Project management

Attention to detail

Education

Bachelor’s degree in Biology, Chemistry, Medical Technology, or related scientific discipline

Advanced degree and/or RAC

Tools

SAP

Job description

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)

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.