This company is committed to hiring Veterans

Regulatory Technical Specialist 2

This job is no longer active. View similar jobs.

POST DATE 8/27/2016
END DATE 10/28/2016

Superior Group Mountain View, CA

Mountain View, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Bachelors Degree


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
Detail Oriented
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:

Go Beyond.
EEO Employer - Minorities / Females / Disabled / Veterans / Sexual Orientation / Gender Identity.


Superior Technical Resources, Inc. provides staff augmentation, direct placement, and outsourced human resource solutions. It offers a range of staffing services, including contract staffing, direct hire, pay rolling services, onsite staffing, and Web-based vendor management programs, as well as Web-enabled automated managed service programs in engineering, design, drafting, finance, human resources, management, information technology, and other professional/technical disciplines.

The company serves aircraft/aerospace, computer, electronics, manufacturing, semiconductor, software, telecommunications, and utilities sectors.