Global Regulatory Affairs Lead – Remote

Cardinal Health; Salt Lake City (UT); Teletrabalho; USD 81 000 - 127 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, dental and vision coverage

Paid time off

401k plan

HSA

Wages access before payday

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Resumo da oferta

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to lead regulatory requirements for international product registrations and global strategies. You will support U.S. convenience kitting activities and collaborate with cross-functional teams to meet US, EU, and international regulatory requirements.

You will drive regulatory submissions, maintain labeling compliance, monitor evolving medical device regulations, and manage regulatory data. Travel up to 10% is expected as needed.

Qualificações

• Bachelor’s Degree in a scientific discipline or equivalent work experience.
• 5+ years regulatory affairs experience preferred.
• Experience in medical device industry a plus.
• Proficiency in International STED, technical documents, and US FDA medical devices regulations highly preferred.
• Strong organizational and problem-solving skills.
• Strong oral and written communication skills.
• Ability to manage multiple projects while maintaining deadlines.
• Ability to travel up to 10% of the time.

Responsabilidades

• Lead regulatory strategy for new and modified product development projects, ensuring regulatory requirements are integrated throughout the product lifecycle.
• Prepare, submit, and maintain global product registrations, including FDA 510(k) submissions, EU Technical Documentation, and International STEDs.
• Collaborate with global and regional regulatory teams to support international market access and ensure timely execution of regulatory strategies.
• Review product labeling to ensure compliance with global regulatory and medical device requirements.
• Monitor, interpret, and assess emerging medical device regulations, providing guidance on business impact and compliance requirements.
• Maintain regulatory intelligence, identify compliance risks, and develop mitigation and resolution strategies.
• Provide regulatory support for customer inquiries, bids and tenders, customs requests, OEM, Private Brand, Presource, and Sustainable Technologies businesses.
• Develop, implement, and maintain regulatory procedures, SOPs, and compliance processes.
• Manage regulatory data, analytics, and reporting through regulatory information management systems, including trend analysis of submission activities.
• Ensure global product and regulatory requirements are effectively implemented and maintained to support ongoing compliance and market access.
• Independently oversees multiple regulatory projects and develops regulatory strategies that optimize and accelerate market access opportunities.

Conhecimentos

Regulatory strategy

Regulatory submissions

Multitasking

Communication

Travel readiness

Formação académica

Bachelors in science or equivalent

Descrição da oferta de emprego

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to lead regulatory requirements for international product registrations and global strategies. You will support U.S. convenience kitting activities and collaborate with cross-functional teams to meet US, EU, and international regulatory requirements.

You will drive regulatory submissions, maintain labeling compliance, monitor evolving medical device regulations, and manage regulatory data. Travel up to 10% is expected as needed.