Senior Regulatory Affairs Leader — Global Submissions

Cardinal Health; Augusta (ME); 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 registrations and support U.S. convenience kitting activities.

You will develop global regulatory strategies and lead regulatory efforts for new product development, manufacturing and product changes, regulatory submissions, and compliance initiatives. You will work with cross-functional teams to ensure compliance with U.S., EU, and international requirements while supporting

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 US FDA medical devices regulations highly preferred.

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.

Skills

Regulatory affairs

Regulatory submissions

Regulatory strategy

Project management

Education

Bachelor’s Degree in a scientific discipline

Job description

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

You will develop global regulatory strategies and lead regulatory efforts for new product development, manufacturing and product changes, regulatory submissions, and compliance initiatives. You will work with cross-functional teams to ensure compliance with U.S., EU, and international requirements while supporting