February 9, 2018 - Regulatory Affairs Contractor - Responsibilities: Prepare and submit product, manufacturing, packaging, or labeling/IFU changes to European Notified Body, as required through Significant Change Supplements or Notifications. Prepare 510(k)'s to FDA pertaining to device changes requiring FDA clearance, as required and as determined by regulatory strategy. Submit notifications to Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc.
https://www.indeed.com/viewjob?t=regulatory+affairs+contractor&jk=f92c04128c455795&_ga=2.228725340.1993267931.1518841385-251423520.1515107595
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