Sr. Specialist, Regulatory Affairs

What Reg Affairs contributes to Cardinal Health

Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.

Accountabilities

  • Manage the regulatory support request process for documentation, SME direction, legalization, etc. in order to maintain global registrations for a range of globally regulated cardiology and endovascular products.
  • Coordinate and compile regulatory submissions, including preparation and maintenance of Certificates of Foreign Government and required legalization activities.
  • Maintain information in various compliance databases and produce reports,
  • Ensure compliance with regulations and guidelines as well as company SOP’s and protocols
  • Some international conference calls, outside of normal working hours, may be necessary.

Qualifications

  • Bachelors’ degree in related discipline and 2+ years related experience in medical device industry.
  • Direct regulatory experience/involvement with international regulatory filings
  • Excellent communication skills.
  • A hands-on, decisive, action-oriented style must be evident.

What is expected of you and others at this level

  • Applies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasks
  • Ability to work independently, applying judgment within defined parameters.
  • Works on projects of moderate scope and complexity
  • Identifies and recommends possible solutions and method of completion to a variety of technical problems. Takes actions to resolve and follows through to completion.
  • Receives general guidance may receive more detailed instruction on new projects
  • Work reviewed for sound reasoning and accuracy
  • Developing good working relationships with global partners