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Job Field: Legal Jobs
Location: San Jose, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Key Responsibilities
         Fully support the Quality Policy by
building quality into all aspects of my work and
by maintaining compliance to all quality
requirements including but not limited to being
current on all training requirements for my
position and documenting that training.
         Acts as company representative,
developing and maintaining positive relationships
with device reviewers through oral and written
communications regarding pre-submission
strategy/regulatory pathway development, testing
requirements, clarification and follow-up of
submissions under review.
         Filings include PMA, 510k, IDE, and
letter-to-file.
         Schedules, plans and conducts meetings
with Office of Device Evaluation.
         Responsible for preparation and
submission of global regulatory applications, as
well as internal regulatory file documentation.
         Plans and coordinates implementation of
validation strategies and schedules with
Engineering, Clinical Research and Quality
Assurance personnel, for multiple project teams.
Please See the Below URL for More Details.

KEY REQUIREMENTS:

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None Bachelors degree