Remote Global Regulatory Strategy Lead

Medline; United States; A distancia; USD 116.000 - 174.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Descripción de la vacante

Medline Industries, LP is seeking a Principal Regulatory Affairs professional for a remote role. You will develop regulatory strategies for global approvals and maintain products, coordinating with regulators to address questions and non-conformances.

You will lead cross-functional groups, drive regulatory pathways, and guide product labeling and claims across markets, with a strong emphasis on international regulatory intelligence and compliance.

Formación

• Bachelor's degree in life science, engineering, regulatory science or related field.
• 5+ years of diverse regulatory experience in medical devices globally.
• Experience authoring/submitting 510(k)s and CE Technical Files; liaising with FDA and Notified Bodies.

Responsabilidades

• Determine regulatory submission requirements for national/multi-national launches.
• Communicate regulatory requirements and pathways to internal/external stakeholders.
• Lead and coordinate internal and external audits and post-audit actions.

Conocimientos

Regulatory experience

Regulatory strategy

FDA submissions

Global regulatory

Educación

Bachelor's degree in life sciences or regulatory field

Descripción del empleo

Medline Industries, LP is seeking a Principal Regulatory Affairs professional for a remote role. You will develop regulatory strategies for global approvals and maintain products, coordinating with regulators to address questions and non-conformances.

You will lead cross-functional groups, drive regulatory pathways, and guide product labeling and claims across markets, with a strong emphasis on international regulatory intelligence and compliance.