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Staff Regulatory Affairs

Staff Regulatory Affairs

Tech DigitalChaska, MN, US
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Global Regulatory Compliance Specialist

In this role, you will have the opportunity to : Author global pre-market submissions, including 510(k)s and PMAs to the U.S. FDA in alignment with pre-market and post-market strategies. Create and manage IVDR Technical Files. Work with international colleagues on establishing design dossiers for their intended market for new product development and design changes.

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Regulatory • Chaska, MN, US

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