Principal Regulatory Affairs Specialist

Responsibilities

• Lead new and modified product development projects to establish and integrate regulatory strategy into project activities.
• Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.
• Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution.
• Review design control documents including documents associated with design inputs and design outputs.
• Review product labeling for compliance with global labeling regulations.
• Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business.
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.
• Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc.
• Development and implementation of regulatory procedures and SOPs.

• Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred.
• 5-7 years regulatory affairs experience preferred.
• Experience in medical device industry a plus.
• Proficiency in 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.