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Regulatory Technical Specialist 2
Superior Group is looking for Regulatory Technical Specialist 2 for our Client located in Mountain View, CA
Effectively implements the complaint handling process and processes complaints in a uniform and timely manner
Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals.
Drive the resolution of product issues in the field, through coordination of investigations, recommending customer bulletins, etc.
Document and maintain records of all complaint investigations in accordance with 21 CFR § 820.198 including failure analysis follow-up
Investigate and develop solutions to procedure and process related issues.
Complete all required customer complaint related documentation in an accurate, professional and timely manner
Present customer complaint investigation facts and details to management for those complaints that may have a potential safety impact
Extensive experience with complaint backlog and FDA remediation’s
Strong critical thinking, problem solving and technical writing skills
Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors
Regulatory knowledge with complaint handling; adverse event reports; recalls; labeling; and quality systems.
Excellent/advanced skills with Excel
Required Skills / Qualifications:
Bachelor's degree in a technical discipline (such as Engineering, Bio-medical Engineering, Computer Science, Biology, or Chemistry)
Minimum 3 years of Regulatory Affairs experience in medical devices (especially products containing software and electro/mechanical components)
Preferred Skills / Qualifications:
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