Regulatory Specialist

Winston Salem, NC 27105

Posted: 06/20/2019 Employment Type: Contract Industry: Admin-Clerical Job Number: 94741
We' re seeking a Regulatory Reporting Specialist for our medical device manufacturing client in Winston-Salem! This is a long-term Contract opportunity that will last approximately 6 months, but potentially longer. The working schedule is 8: 00am-5: 00pm, with a an excellent pay rate. Responsibilities of the Regulatory Reporting Specialist will include reporting to regulators, responding to questions, supporting sister companies, and coordinating and monitoring field action. The ideal candidate must have senior level regulatory experience, preparing 806 and Field Safety Corrective Action reports. If you feel you meet this criteria and are pursuing new opportunities, we' d love to speak with you!

Responsibilities & Qualifications:
- Will be responsible for Recall and Field Safety Corrective Action (FSCA) reporting to regulators and responding to questions
- Support sister companies reporting to other regulators globally, and responding to those questions if needed
- Coordinate and monitor the field action globally
- Experience conducting Class II FDA recalls and Field Safety Corrective Actions in EU
- Recall experience in Regulatory, preparing the reports and communicating with all of the customer service recall coordinators globally to carry out the recall
- Somewhat extensive experience in Regulatory preparing 806 and FSCA Reports, responding to Regulators questions, preparing Customer Letters, and implementing recalls globally

Submit your resume online, or email directly to ckelly-corne@theresource.Com to be considered for this position. For additional information, please call or text our office at 336.970.5237.
While we appreciate all inquiries, only qualified candidates will be contacted for further information.
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