Regulatory Diagnostics Manager

Company: VirtualVocations
Location: Marietta
Posted on: September 14, 2023

Job Description:

A company is looking for a Manager, Regulatory Diagnostics.
Key Responsibilities:

Develop and coordinate IVD related regulatory submissions in line with program strategies
Lead authoring of IVD related regulatory documentation
Interface with outside regulatory agencies for application submission and management

Required Qualifications:

Bachelor's degree required; advanced degree preferred
Minimum of 5 years of experience in the biotechnical or pharmaceutical industry
Minimum of 2 years experience in a regulatory capacity, or 5 years of experience with in-vitro diagnostic development for companion diagnostics
Experience with FDA and ICH regulatory guidance and regulations
Understanding of FDA structure and functions; knowledge of/experience with regulatory requirements for other regions also desirable

Keywords: VirtualVocations, Marietta , Regulatory Diagnostics Manager, Executive , Marietta, Georgia

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