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Job Field: Legal Jobs
Location: Santa Clara, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Other responsibilities include identifying
relevant standards and guidance documents that
affect the companys business and products,
assisting with FDA facility inspections and
notified body audits and making MDR or Vigilance
report recommendations as appropriate.
Determines global regulatory pathways for various
projects including project classification and type
of regulatory submission or rationale required.
Participates on project teams to define
regulatory requirements of U.S. and international
submissions, technical files or regulatory
rationales.
Identifies guidance documents, international
standards and consensus standards and assists
teams with their interpretation.
Prepares regulatory submissions to the FDA, the
competent authorities and other regulatory
authorities.
Prepares for pre-IDE meetings and assists with
clinical trials when required.
Interacts with various levels of management,
external agencies and companies.
Analyzes and makes recommendations regarding
complaints received by the company and whether
they are MDR or vigilance reportable participates
in complaint investigations and CAPA reviews as
appropriate.
Provides regulatory training when needed.
Acts as liaison with appropriate local, national
and international regulatory authorities.
Provides regulatory guidance to sales, marketing,
and manufacturing groups, as appropriate, for both
onsite and remote activities.
Reviews changes in manufacturing facilities,
manufacturing procedures, and analytical methods.
Identifies and monitors schedules for submission
documentation, documentation review, protocols and
reports prepares additional written materials as
needed.
Prepares responses to FDA letters, supplements,
and amendments participates in ISO and customer
audits and FDA inspections and presentations.
Writes standard operating procedures as needed.
Provides input for the preparation of the
departmental budget ensures that the department
operates within capital and expense budget
guidelines.
Keeps informed of new regulations, standards,
policies, and guidance issued by relevant
regulatory authorities that may impact the
company.
Performs other related duties and task, as
required...For more information please see the url

KEY REQUIREMENTS:

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None Associate degree