Senior Global Regulatory Affairs Lead – Remote

Cardinal Health; Boise (ID); 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

Flexible spending accounts

Disability coverage

Parental leave

Job summary

Cardinal Health seeks a Principal Regulatory Affairs Specialist to drive regulatory strategy for international product registrations and U.S. convenience kitting activities.

You will lead regulatory efforts for new product development, manufacturing changes, and global submissions, coordinating with cross-functional teams to ensure compliance and market access. You will collaborate on global strategies, review labeling, and monitor evolving medical device regulations, delivering timely

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.
• Develop, implement, and maintain regulatory procedures, SOPs, and compliance processes.

Skills

Regulatory affairs experience

Project management

Communication skills

Organizational skills

Deadline management

Travel ability

Regulatory strategy

Education

Bachelor's Degree in Science

Job description

Cardinal Health seeks a Principal Regulatory Affairs Specialist to drive regulatory strategy for international product registrations and U.S. convenience kitting activities.

You will lead regulatory efforts for new product development, manufacturing changes, and global submissions, coordinating with cross-functional teams to ensure compliance and market access. You will collaborate on global strategies, review labeling, and monitor evolving medical device regulations, delivering timely