Remote Principal Regulatory Affairs Leader

Cardinal Health; Salem (OR); Remote; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Health savings account (HSA)

MyFlexPay wage access

Job summary

Cardinal Health seeks a Principal Regulatory Affairs Specialist to manage regulatory requirements for international product registrations, develop global strategies, and support U.S. convenience kitting activities.

The role leads regulatory efforts for new product development, manufacturing changes, regulatory submissions, and cross-functional collaboration to meet US, EU, and international requirements. You will monitor regulations, maintain regulatory intelligence, review labeling, and support

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent work experience.
• 5+ years of regulatory affairs experience preferred.
• Experience in medical device industry is a plus.
• Strong knowledge of international STED, US FDA medical devices regulations.

Responsibilities

• Lead regulatory strategy for new and modified product development projects and lifecycle.
• Prepare, submit, and maintain global product registrations (FDA 510(k), EU Technical Documentation).
• Collaborate with global/regional teams to support international market access.
• Review labeling to ensure compliance with global regulatory requirements.
• Monitor emerging medical device regulations and provide guidance.
• Maintain regulatory intelligence and risk mitigation strategies.

Skills

Regulatory affairs

Project management

Written communication

Oral communication

Organizational skills

Travel readiness

Education

Bachelor’s degree in a scientific discipline

Tools

Regulatory information management systems

Job description

Cardinal Health seeks a Principal Regulatory Affairs Specialist to manage regulatory requirements for international product registrations, develop global strategies, and support U.S. convenience kitting activities.

The role leads regulatory efforts for new product development, manufacturing changes, regulatory submissions, and cross-functional collaboration to meet US, EU, and international requirements. You will monitor regulations, maintain regulatory intelligence, review labeling, and support