Remote Global Regulatory Affairs Lead

Cardinal Health; Richmond (VA); Remote; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Parental leave

Flexible spending accounts (FSAs)

Job summary

Cardinal Health seeks an experienced Principal Regulatory Affairs Specialist to manage international product registrations and global regulatory strategies. You’ll lead regulatory efforts for new product development, manufacturing changes, and submissions while coordinating with cross-functional teams to meet U.S., EU, and global requirements.

Travel up to 10% may be required. You will support regulatory intelligence, develop SOPs, and drive continuous improvement in compliance programs.

Qualifications

• 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 travel up to 10% of the time.

Responsibilities

• 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.

Skills

Regulatory strategy

FDA submissions

EU technical docs

US FDA regulations

Regulatory submissions

Travel readiness

Education

Bachelor’s degree in science

Job description

Cardinal Health seeks an experienced Principal Regulatory Affairs Specialist to manage international product registrations and global regulatory strategies. You’ll lead regulatory efforts for new product development, manufacturing changes, and submissions while coordinating with cross-functional teams to meet U.S., EU, and global requirements.

Travel up to 10% may be required. You will support regulatory intelligence, develop SOPs, and drive continuous improvement in compliance programs.