Remote Principal Regulatory Strategy Lead

Cardinal Health; Lincoln (NE); Remote; USD 81,000 - 127,000; Full time

Job summary

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to manage regulatory requirements for international product registrations and support U.S. convenience kitting activities.

You will lead regulatory efforts for new product development, manufacturing changes, regulatory submissions, and compliance initiatives, collaborating with cross-functional teams. This role ensures products meet U.S., EU, and international regulatory requirements, while supporting business objectives and

Qualifications

• Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred.
• 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.

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 affairs experience

Medical device experience

FDA/Regulations knowledge

Organizational skills

Problem solving

Communication skills

Project management

Travel ability

Education

Bachelor’s Degree in science

Job description

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to manage regulatory requirements for international product registrations and support U.S. convenience kitting activities.

You will lead regulatory efforts for new product development, manufacturing changes, regulatory submissions, and compliance initiatives, collaborating with cross-functional teams. This role ensures products meet U.S., EU, and international regulatory requirements, while supporting business objectives and