Mirrai Careers

Regulatory Affairs Specialist I

Company hidden

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, assist in preparing various submissions to gain approvals, such as 510(k), CE Mark Technical Documentation, UKCA Mark, other regional Regulatory submissions, IDE, non-US Clinical Trial Submission, Shonin,…

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