Regulatory Affairs Doc Coordinator III
Position Type :
Experience Level :
Start Date / End Date :
02/11/2013 / 12/31/2013
The RA Document Coordinator will be responsible for the coordination and compilation of technical documentation to support regulatory applications in the EU (Technical Files, Design Dossiers) and US (510(k), BLA, PMA, IDE, IND, Annual Reports). The RA Document Coordinator will also be responsible for maintaining, organizing, and ensuring protection of regulatory files. The ideal candidate will have excellent organization skills and the ability to manage multiple projects. At times, the RA Document Coordinator will work independently to obtain data needed to support regional regulatory submissions, as identified by the RA team. The candidate will also maintain collaborative relationships with Product Support, R&D, Operations, and quality partners.
An Associate’s Degree is required. Candidate must have the ability to organize data and identify issues or gaps in documentation, and have the ability to effectively communicate in oral and written forms.
Bachelors degree required and 5+ years experience.