Principal Regulatory Affairs Specialist

Cardinal Health•Waukegan, IL

1d•Hybrid

About The Position

The Principal Regulatory Affairs Specialist will support the Medical Solutions Regulatory affairs team. They are responsible for regulatory activities associated with convenience kitting (Presource® kitting). This includes being regulatory lead for strategy, 510ks, and FDA regulations for the kitting products.

Requirements

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.

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.