Regulatory Affairs Specialist II

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Alameda, CA Posted 30+ days ago

In this role, you will work with the team that ensures that the company products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions. What You’ll Work On • Under direct supervision, prepare moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory…

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