Especialista Regulatory Affairs

iLine Microsystems is currently in a consolidated phase of growth and expansion and therefore needs to incorporate a person in the Quality Department. Reporting directly to the Regulatory Affairs and Quality Director, this position is integrated in a multidisciplinary department and it has the following responsibilities and tasks: - To actively participate...

Draft and prepare product technical documentation for CE marking activities and notified body interaction to accomplish EU MDR product authorization - Understand and interpret EU and US medical device regulatory requirements - Develop regulatory strategies and plans for submissions for international product registrations - Draft and prepare 510(k)...

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