Senior Manager, Regulatory Affairs - IVD
Clinical Careers Page(2 months ago)
About this role
A Senior Manager, Regulatory Affairs - IVD at ICON is a senior regulatory leader within a global clinical research organization focused on regulatory strategy and client advisory for in vitro diagnostics. The role supports clinical development programs and contributes to ICON’s mission of advancing innovative treatments and therapies. The position is US-remote with a preference for the Portland, OR area.
Required Skills
- Regulatory Strategy
- Submission Planning
- Agency Interaction
- Document Writing
- Clinical Trials
- GCP Compliance
- Regulatory Intelligence
- Project Management
- Stakeholder Engagement
- Leadership
About Clinical Careers Page
iconplc.comICON plc is a global clinical research organisation (CRO) that provides outsourced clinical development and commercialisation services to pharmaceutical, biotechnology and medical device companies. It offers end-to-end drug and device development support — including clinical trial management across phases, data management and biostatistics, regulatory and safety/pharmacovigilance, and commercialisation and market-access services. ICON combines scientific and therapeutic expertise with technology and a scalable global operations network to accelerate development and bring therapies to patients. Clients engage ICON for integrated, experienced CRO support across the full product lifecycle.
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