Temp to Perm - Remote Opportunity - Regulatory Affairs Manager
CollaberaUnited States only
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- Required: (Remote Opportunity - Temp to Perm)
- The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
- In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
- The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.