Global Regulatory Affairs Manager, Medical Devices (Hybrid)

Medline Industries; Eagan (MN); Híbrido; USD 116.000 - 174.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401(k) contributions

Paid time off

Life and disability

Descripción de la vacante

Medline Industries is hiring a Manager Regulatory Affairs in Eagan, MN with a hybrid work model. The role oversees regulatory affairs for Medline product lines, guiding teams to develop and execute strategies for domestic and international approvals of medical devices.

The position requires a Bachelor's degree in Regulatory Affairs or related field and 4+ years of regulatory experience. SAP experience and 510(k)/CE filing know-how are preferred. Up to 15% travel may be required.

Formación

• Bachelor’s degree in Regulatory Affairs, Life Sciences or Engineering.
• At least 4 years of regulatory affairs experience for medical devices.
• Ability to lead regulatory filings and develop strategies for domestic and international approvals.

Responsabilidades

• Guide regulatory decision-making based on medical device requirements.
• Lead regulatory filings with internal and external groups.
• Develop and implement regulatory processes for pre- and post-market activities.
• Communicate regulatory requirements to stakeholders and regulators.
• Monitor regulatory changes and adjust strategies accordingly.

Conocimientos

Regulatory affairs

Regulatory strategy

Project management

Communication

SAP

510(k) preparation

FDA regulations

Microsoft Word

Microsoft Excel

Educación

Bachelor's degree in Regulatory Affairs/Life Sciences/Engineering

Herramientas

SAP

Microsoft Word

Microsoft Excel

Descripción del empleo

Medline Industries is hiring a Manager Regulatory Affairs in Eagan, MN with a hybrid work model. The role oversees regulatory affairs for Medline product lines, guiding teams to develop and execute strategies for domestic and international approvals of medical devices.

The position requires a Bachelor's degree in Regulatory Affairs or related field and 4+ years of regulatory experience. SAP experience and 510(k)/CE filing know-how are preferred. Up to 15% travel may be required.