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Job Field: Legal Jobs
Location: EVERETT, WA
Salary: $-
Job Type: Part Time

JOB SUMMARY:

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               <td align="left"><font style="font-size: 100%;">Title: Regulatory Affairs Specialist III<BR>Location: North America-United States-wa-Everett<BR>Job Number:_FLU000850<BR>Fluke Biomed has an immediate opening for aRegulatory Affairs Specialist III. If you are the kind of person who thrives working in a fast paced environment, relishes working across departments within a business, has keen eye for detail and enjoys preparing data for Medical Device Audits(Corporate and FDA), then keep reading.<BR><BR>As the Regulatory Affairs Specialist (RAS) you will perform the coordination and preparation of document packages for regulatory submissions from all areas of company as well as support corporate/FDA audits. Assist R&D in development of new 510(k) documentation, review marketing literature for compliance and research and register products with foreign countries.<BR><BR>Responsibilities:<BR>* Coordinate and prepare documentation packagers for submissions(ensure data accuracy)<BR>* Gather all needed paperwork, data and materials needed for license renewal and annual registration<BR>* Review marketing literature, verify changes and adds as FDA compliant<BR>* Prepare for company audits as well as FDA audits<BR>* Collaborate with various departments to determine 510(k) actions<BR><BR><BR>* Bachelor&#39;s degree in related field(science related preferred)<BR>* 2-5 years working with US FDA Medical Device Regulations<BR>* Strong working knowledge of FDA Regulations<BR>* Prior experience preparing new 510(k), and making changes as needed<BR>* Excellent written, oral communication and interpersonal skills<BR>* Eye for detail, and ability to create accurate work under tight deadlines<BR><BR><BR>All external hiring is contingent upon the successful completion of a pre-employment drug screen and a criminal background check.<BR><BR>Fluke Corporation is an equal opportunity employer<BR>www.fluke.com,www.danaher.com<BR><BR>Job: Legal & Compliance                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  </font></td>
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