Senior Regulatory Affairs Lead Global Submissions (Remote)

Cardinal Health; Helena (MT); A distancia; USD 81.000 - 127.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Flexible spending accounts (FSAs)

Short- and long-term disability

Descripción de la vacante

Cardinal Health seeks a Principal Regulatory Affairs Specialist to manage regulatory requirements for international registrations, develop global strategies, and support U.S. convenience kitting.

The role leads regulatory efforts for new product development, manufacturing changes, regulatory submissions, and compliance initiatives across markets. The position collaborates with cross-functional teams to ensure products meet U.S., EU, and international requirements while driving business

Formación

• Bachelor’s degree in a scientific field or equivalent experience.
• 5+ years in regulatory affairs preferred.
• Experience with medical devices and FDA/device regulations a plus.
• Strong organizational and problem-solving abilities.
• Excellent written and oral communication skills.

Responsabilidades

• Lead regulatory strategy for new and modified product development projects.
• Prepare, submit, and maintain global product registrations (FDA 510(k), EU Technical Documentation).
• Collaborate with global/regional teams to support international access and timely execution of strategies.
• Review labeling for global regulatory compliance.
• Monitor and interpret evolving medical device regulations and impact on business.

Conocimientos

Regulatory strategy

Cross-functional collaboration

FDA knowledge

Regulatory submissions

Project management

Communication skills

Educación

Bachelor’s Degree in a scientific discipline

Descripción del empleo

Cardinal Health seeks a Principal Regulatory Affairs Specialist to manage regulatory requirements for international registrations, develop global strategies, and support U.S. convenience kitting.

The role leads regulatory efforts for new product development, manufacturing changes, regulatory submissions, and compliance initiatives across markets. The position collaborates with cross-functional teams to ensure products meet U.S., EU, and international requirements while driving business