Regulatory Technical Specialist 2
This job is no longer active.
View similar jobs.
POST DATE 9/15/2016
END DATE 10/15/2016
Mountain View, CA
JOB DESCRIPTION* 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 remediations
* Strong critical thinking, problem solving, and technical writing skills
* Detail Oriented
* Ability to work on problems of diverse scope where analysis of a situation or data requires evaluation of various factors
* Qualified applicants must have a Bachelor's degree in a technical discipline (such as Engineering, Bio-medical Engineering, Computer Science, Biology, or Chemistry) or an equivalent combination of relevant experience and education.
* 3-5 years Regulatory Affairs experience in medical devices (especially products containing software and electro/mechanical components)
* Regulatory knowledge with complaint handling; adverse event reports; recalls; labeling; and quality systems.
* Excellent/advanced skills with Excel