Global Regulatory Affairs Lead (Remote)

Cardinal Health; Santa Fe (NM); Remote; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

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

You will lead regulatory efforts for new product development, manufacturing and product changes, and regulatory submissions while ensuring compliance with US, EU, and international requirements.

Qualifications

• Bachelor's degree in a scientific field or equivalent experience.
• 5+ years in regulatory affairs preferred.
• Experience with medical devices and FDA/EU requirements preferred.
• Strong organizational and problem-solving skills.
• Excellent written and verbal communication.

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

Global regulatory knowledge

Regulatory writing

Project management

Communication skills

Travel readiness

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 product registrations, developing global regulatory strategies, and supporting U.S. convenience kitting activities.

You will lead regulatory efforts for new product development, manufacturing and product changes, and regulatory submissions while ensuring compliance with US, EU, and international requirements.