Global Regulatory Affairs Lead – IVDR/IVD Expert (Hybrid)

ManpowerGroup; Irvine (CA); Híbrido; USD 76.000 - 83.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Competitive pay

Global regulatory initiatives

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory knowledge

Regulatory writing

FDA/IVDR regulations

Quality management systems

SAP

Statistical analysis

Analytical skills

Communication skills

Project management

Attention to detail

Educación

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

Advanced degree and/or RAC

Herramientas

SAP

Descripción del empleo

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.