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Associate Director, Regulatory Affairs
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- The Associate Director, Regulatory Affairs works as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications.
- This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit.
- The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products.
- The incumbent will actively support the development of regulatory strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients.
- Manage premarket submissions for regulatory approval of in vitro companion diagnostic medical devices in the US market.
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