Global Regulatory Strategy Lead (Remote)

Cardinal Health; Hagåtña (GU); Remote; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical coverage

Paid time off

HSA

401(k) plan

Disability coverage

Job summary

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

You will lead regulatory efforts for new product development, changes, and submissions, collaborating with cross‑functional teams to ensure compliance across US, EU, and international markets.

Qualifications

• Bachelor’s degree or equivalent with science background.
• 5+ years regulatory affairs experience preferred.
• Experience in medical device industry is a plus.
• Proficiency with International STED and US FDA medical devices regulations.

Responsibilities

• Lead regulatory strategy for new and modified product development across lifecycle.
• Prepare, submit and maintain global registrations (FDA 510(k), EU Technical Documentation).
• Collaborate with global/regional teams to support market access and timely execution.
• Review labeling to ensure compliance with global medical device requirements.
• Monitor and interpret emerging medical device regulations; provide guidance on impact.
• Maintain regulatory intelligence and risk mitigation strategies.
• Develop, implement, and maintain regulatory SOPs and procedures.
• Oversee multiple projects and identify risks with proactive solutions.

Skills

Regulatory strategy

Global registrations

Regulatory submission

Communication skills

Travel readiness

Education

Bachelor’s Degree in a scientific discipline

Job description

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

You will lead regulatory efforts for new product development, changes, and submissions, collaborating with cross‑functional teams to ensure compliance across US, EU, and international markets.