Regulatory Reporting Specialist

Winston Salem, NC 27105

Posted: 08/23/2019 Employment Type: DirectHire Industry: Admin-Clerical Job Number: 95923
We' re seeking a Regulatory Reporting Specialist for our medical device manufacturing client in Winston-Salem! This is a full time, permanent Direct Hire position that offers a very competitive pay rate. Responsibilities include assessing complaints for Regulatory Reporting. Duties will also include handling Adverse Event Reporting (MDR, Vigilance, etc.) and associated correspondence to applicable regulatory bodies, responding to questions, supporting sister companies, and coordinating and monitoring field action.

If you feel you meet this criteria and are pursuing new opportunities, we' d love to speak with you!

Essential Duties & Responsibilities:
- Review and assess product complaints received from global distribution centers
- Assess complaints for adequate information to determine if event meets Regulatory Reporting requirements
- Utilize appropriate complaint software systems for processing complaints to/from distribution centers and QE Investigation functions
- Generate appropriate regulatory reports based on assessment
- Generate responses to inquiries on AE reports from various global regulatory authorities
- Generate various reports, including but not limited to, Regulatory requests, Marketing requests, Engineering requests
- Assist in coordination of Recall administration activities between manufacturer and distribution centers
- Assess complaints of class II through IV devices
- Generate adverse event reports, code properly
- Must work and interact effectively and professionally with and for others throughout various levels of the global organization
- Must strictly adhere to safety requirements

- Bachelor' s degree in a technical discipline or communications, or equivalent work experience (3-5 years)
- Computer experience required with working knowledge of Microsoft Office programs and proficient keyboarding skills
- Experience with USA and EU reporting
- Must have effective oral and written communication skills
- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
- Ability to remain calm and receptive in fast paced situations
- Ability to adapt to change and multi-task
- Excellent organizational skills a must with ability to work within defined deadlines

Submit your resume online, or directly to jyeargan@theresource.Com to be considered for this position. For additional information, please call or text our office at 336.970.5214.

While we appreciate all inquiries, only qualified candidates will be contacted for further information.
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