Senior Regulatory Affairs Specialist

Job Description

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Patient Recovery Regulatory Affairs team.  The selected candidate will provide regulatory support on a range of medical devices which include support of change development projects, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Patient  Recovery business.

The Principal Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects.  Specific activities include but are not limited to:

  • Lead the preparation, submission, and maintenance of global product registrations with a focus on U.S. 510(k)s, EU Technical Documentation aligned with new EU Medical Device Regulation and STED
  • Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
  • Review pre-clinical documentation with focus on compliance to design control
  • Review product labeling for compliance with global labeling regulations
  • Review advertising and promotional literature for compliance with applicable regulations
  • Interpret and evaluate proposed regulations and advise on impact of such regulations on the business
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies



  • Bachelor’s Degree in a scientific discipline


  • 5-7 years Regulatory Affairs Experience or equivalent
  • Majority of Regulatory Affairs experience in Medical Device industry preferred


  • Proficiency in US and Europe medical device regulations
  • Strong organizational skills
  • Ability to manage multiple projects
  • Deadline conscious
  • Problem solving skills
  • Team oriented
  • Strong oral and written communication skills

Other skills:

  • Fluent in local language required


  • Travel time required, up to 5%


  • General office environment

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.