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Manager Regulatory Affairs, in Vitro Diagnostics And Companion Diagnostics (Remote)
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Full-time
Remote
- We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
- The Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives.
- Builds and maintains relationships with relevant stakeholders including Regulatory Affairs functional areas, Precision Medicine, Medical Affairs and Commercial organizations.
- Assists with preparation of submissions, supplements, and correspondence with regulatory authorities, including Performance Evaluation Applications under IVDR, requests for Study Risk Determinations and Investigational Device Exemption (IDE) applications.
- Represents RA Device on product development teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.
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