Remote Regulatory Affairs Leader – Medical Devices

W. L. Gore & Associates; United States; A distancia; USD 150.000 - 210.000; Jornada completa

Descripción de la vacante

W. L. Gore & Associates is seeking a Regulatory Affairs Leader for the Aortic Business Group. You will plan, develop, and coordinate regulatory strategies to obtain and maintain global approvals for new and existing products, with leadership for Regulatory Associates on global submission planning.

This remote role supports the United States and requires collaboration with cross-functional teams to ensure regulatory compliance and timely submissions across markets.

Formación

• Bachelor's degree required with at least 8 years in medical device Regulatory Affairs.
• Extensive knowledge of FDA and international regulations related to Class III implantable devices and PMA submissions.
• Experience leading regulatory teams and coordinating global submissions.

Responsabilidades

• Provide direction for regulatory team members for pre- and post-market strategies and submission planning.
• Lead and manage Regulatory Associates through goals and responsibilities.
• Improve regulatory processes and ensure timely compliance and submissions across global markets.
• Collaborate with cross-functional teams to meet timelines and regulatory expectations.
• Partner with Regulatory Affairs Business Leader to align business and regulatory goals.
• Mentor Regulatory Associates in regulatory deliverables, labeling, and compliance.

Conocimientos

Regulatory leadership

Global regulatory strategies

Cross-functional collaboration

PMA submission knowledge

FDA and international regulations

Project management

Communication

People leadership

Educación

Bachelor's degree

Descripción del empleo

W. L. Gore & Associates is seeking a Regulatory Affairs Leader for the Aortic Business Group. You will plan, develop, and coordinate regulatory strategies to obtain and maintain global approvals for new and existing products, with leadership for Regulatory Associates on global submission planning.

This remote role supports the United States and requires collaboration with cross-functional teams to ensure regulatory compliance and timely submissions across markets.