Experience:
No experience
Employment Type:
Full time
Posted:
9/6/2017
Job Category:
Health Care Provider
Industry:
Other
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Document Processor II at Eugene OR
Software Specialists | Eugene, Oregon
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Job Description

Hi,

This is Rohini with SSI, We have an immediate opening for Document Processor II with our Direct client. If you are interested please reach me with your Updated Resume

Title: Document Processor II
Duration: 7months + (Possible Extension)

Location: Eugene OR

Qualifications:

  • Required: Minimum of bachelor's degree. The individual must be highly organized and detail oriented, while having the ability to assess the critical areas needed for documentation and record-keeping. This position requires an individual with strong inter-personal communication skills.
  • Preferred: Experience in regulatory related field. Knowledge of GCP, ISO 13485, and FDA quality system regulation and other regulatory requirements commonly used in clinical and medical device settings.

Purpose of the position/Job Summary:

  • The primary purpose of this position is to assist in the establishment and maintenance of regulatory compliance. In large part, this is accomplished through submission, organization and maintenance of regulatory records.

Scope & Impact:

  • Research involving human participants, and the development and use of medical device requires the timely and precise organization of regulatory documents. It is imperative that regulatory documentation reflect the changing requirements of regulations and interpretation of those changes.

Major Responsibilities:

  • Submit and track regulatory documents to Institutional/Independent Review Boards (IRB), sponsors, and other regulatory bodies
  • Maintain regulatory study binders and any associated clinical and regulatory records as deemed necessary
  • Prepare for and handle study monitor visits
  • Support regulatory meetings and trainings, including generate and maintain meeting minutes
  • Assist with submission of the 510(k) applications, annual reports or other correspondence to the Food & Drug Administration (FDA)
  • Maintain clinical trial registration sites
  • Assist with standard operating procedures (SOP) and working instruction documents (WID) creation, updates, and maintenance
  • QC of regulatory functions (eg consent form review)
  • Additional responsibilities as deemed necessary by supervisor

Qualifications

Applicants must be eligible to work in the specified location

About Software Specialists

SCS, Inc. has for thirty years successfully provided a wide range of businesses with effective software solutions. SCS principals authored software which evolved into nationally recognized financial packages. SCS focuses on mid-range markets, but its expertise and support expands to multinational corporations, Fortune 500 companies and large government entities. SCS's President was elected President of the prestigious Software Council of Southern California in 1998, acknowledging decades of solid SCS accomplishment. SCS is the largest Navision Solution Center in the West US and is among the leading Solution Centers for Navision Software worldwide. We have implemented and customized Navision Software in over 350 companies in over 20 different industries.

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