Job Number: 20016306

Location: Milpitas, CA

Date Posted: 7-22-2017

Job Title: Advisor, Regulatory Affairs

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What Reg Affairs Manufacturing FDA contributes to Cardinal Health

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

Accountabilities

  • Strategize and prepare domestic and international regulatory filings such as 510(k), IDE, PMA, Annual Reports, and Design Dossier submissions, including subsequent revisions/supplements and amendments.
  • Represent regulatory function on project teams and provide input on regulatory strategy.
  • Communicate with domestic and international regulatory bodies.
  • Review and approve advertising and promotion materials in compliance with FDA regulations and guidelines.
  • Review and approve Engineering Change Requests, CAPAs, NCRs, and Complaints.
  • Maintain information in various compliance databases and produce reports as needed.
  • Ensure compliance with FDA and EU regulations including relevant company SOPs and protocols.
  • Support internal and external audits as needed.
  • Manage a well-organized filing system of all regulatory files.

Qualifications

  • Bachelor’s degree or higher in a relevant technical or scientific field is required.
  • 4+ years of experience in regulatory submissions required.
  • Experience in direct communication with regulatory agencies.
  • Prior experience as a project leader with strong project management skills.
  • Advanced degree and/or regulatory affairs certification (RAC) preferred.
  • Excellent written and oral communication skills; technical writing capabilities are a must.
  • A hands-on, decisive, action-oriented style preferred.

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
  • Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
  • Completes work independently receives general guidance on new projects
  • Work reviewed for purpose of meeting objectives
  • May act as a mentor to less experienced colleagues

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.


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