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.
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.
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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