Global Regulatory Affairs Lead – Medical Devices (Remote)

Cardinal Health; Northern (KY); Hybrid; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision

Paid time off

Health savings account

401k savings plan

Early wage access

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Wellness programs

Job summary

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for international product registrations and U.S. kitting activities. You will prepare submissions, maintain registrations, and coordinate with global teams to meet FDA and EU requirements.

This role manages multiple projects, interprets changing medical device regulations, and drives compliance across product lifecycles while supporting business goals.

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 manage multiple projects while traveling up to 10%.

Responsibilities

• Lead regulatory strategy for new and modified product development projects, ensuring regulatory requirements are integrated throughout the lifecycle.
• Prepare, submit, and maintain global product registrations, including FDA 510(k) submissions and EU Technical Documentation.
• Collaborate with global/regional teams to support market access and timely regulatory execution.
• Review labeling to ensure compliance with global medical device requirements.
• Monitor evolving medical device regulations and provide guidance on business impact and compliance.
• Maintain regulatory intelligence, identify risks, and develop mitigation strategies.
• Develop, implement, and maintain regulatory procedures, SOPs, and compliance processes.

Skills

Regulatory affairs

Regulatory strategy

Medical devices

FDA regulations

Technical writing

Project management

Travel readiness

Education

Bachelor’s degree in a scientific discipline

Job description

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to lead regulatory strategies for international product registrations and U.S. kitting activities. You will prepare submissions, maintain registrations, and coordinate with global teams to meet FDA and EU requirements.

This role manages multiple projects, interprets changing medical device regulations, and drives compliance across product lifecycles while supporting business goals.