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 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.
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.
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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