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Diagnostic Regulatory Affairs Manager
A company is looking for a Diagnostic Regulatory Affairs Manager. Key Responsibilities Provide strategic and tactical regulatory guidance for in vitro diagnostics (IVDs) and companion diagnostics (CDx) Develop regulatory strategies for successful study designs and timely product registrations Lead interactions with diagnostic partners and regulatory agencies to align on co-development needs and submissions Required Qualifications In-depth knowledge of regulatory document management systems, including VeevaVault Doctorate degree or equivalent experience in regulatory affairs Master's degree with 3 years, Bachelor's degree with 5 years, Associate's degree with 10 years, or high school diploma/GED with 12 years of relevant experience Experience in Health Agency, Med-Device, or Regulatory environments Preferred: MS Degree and 6+ years in Regulatory Affairs related to medical devices or IVD/CDx
A company is looking for a Diagnostic Regulatory Affairs Manager.
Key Responsibilities
Provide strategic and tactical regulatory guidance for in vitro diagnostics (IVDs) and companion diagnostics (CDx)
Develop regulatory strategies for successful study designs and timely product registrations
Lead interactions with diagnostic partners and regulatory agencies to align on co-development needs and submissions
Required Qualifications
In-depth knowledge of regulatory document management systems, including VeevaVault
Doctorate degree or equivalent experience in regulatory affairs
Master's degree with 3 years, Bachelor's degree with 5 years, Associate's degree with 10 years, or high school diploma/GED with 12 years of relevant experience
Experience in Health Agency, Med-Device, or Regulatory environments
Preferred: MS Degree and 6+ years in Regulatory Affairs related to medical devices or IVD/CDx