Job Number: 20016311

Location: Miami Lakes, FL

Date Posted: 7-22-2017

Job Title: Manager, 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 regulatory filings such as IDE, PMA and Design Dossier submissions and subsequent revisions/supplements and amendments.
    • Represent regulatory function on project teams on a regular basis and provide input into regulatory strategies for various projects
    • Provides guidance on regulatory environment, compliance practices, and enforcement strategies
  • Manage and execute regulatory submissions
  • Prepare presentations to FDA reviewers and/or inspectors as needed
  • Review and approve Product Incident and MDR reports
  • Review and approve Documents Change Order requests, CAPA’s, NCR’s, etc.
  • Ensure compliance with FDA and European regulations and guidelines as well as relevant company SOP’s and protocols
  • Strategize and prepare international product registrations and licensing documentation..
  • Manage various integration and Cardinal related project plans.
  • Maintain information in various compliance databases and produce reports as needed
  • Manage the maintenance of a well-organized filing system of all regulatory files
  • Perform internal and supplier audits as needed.

Qualifications

  • Bachelor’s degree in a related field and 8+ years experience in health-care related industries (hospitals, labs, pharma, IVD or devices), including previous Regulatory Affairs experience and 3 or more years experience in the medical device industry.
  • Experience and involvement with MDRs, IDEs, PMAs and 510(k) filings
  • Experience in direct communication with regulatory agencies
  • Experience with international regulatory filings a plus
  • An advanced degree is desirable. Interventional cardiology experience would be a plus
  • Excellent written and oral communication skills; technical writing capabilities are a must
  • A hands-on, decisive, action-oriented style must be evident

What is expected of you and others at this level

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Participates in the development of policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope
  • Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts 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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