Hiring: Principal Regulatory Affairs Specialist Company: Cardinal Health Location: Mansfield, MA Job Posted Time: 2026-09-10 11:24:31 Employment Type: Remote About the job Experience: •5+ years regulatory affairs experience preferred. Required Skills: •This is a remote position, and the ideal candidate will be located near or willing to travel to Waukegan, IL or Mansfield, MA. •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. •Partner cross-functionally 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. Qualifications: •Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred. •Proficiency in US and Europe medical devices regulations highly preferred. •Strong organizational and problem-solving skills. •Strong oral and written communication skills. •Demonstrated capacity to manage multiple projects while maintaining deadlines. •Demonstrated capacity to travel up to 10% of the time. •What is expected of you and others at this level •Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects •May contribute to the development of policies and procedures •Works on complex projects of large scope Compensation: •$80,900 - $127,050 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!