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How do they match:
Regulatory Affairs Specialists
2
Alternate Occupation Titles
Product
Safety Specialist
Risk
and
Compliance Analyst
1
O*NET-SOC Description
Coordinate
and
document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile
and
prepare
materials for submission to regulatory agencies.
15
Tasks
Prepare
or direct the
preparation
of additional information or responses as requested by regulatory agencies.
Prepare
or maintain technical files as necessary to obtain
and
sustain
product
approval.
Prepare
responses to customer requests for information, such as
product
data, written regulatory affairs statements, surveys, or questionnaires.
Advise project teams on subjects such as
premarket
regulatory requirements, export
and
labeling requirements, or clinical study compliance issues.
Communicate with regulatory agencies regarding
pre
-submission strategies, potential regulatory pathways, compliance test requirements, or clarification
and
follow-up of submissions under review.
Coordinate efforts associated with the
preparation
of regulatory documents or submissions.
Coordinate,
prepare
, or review regulatory submissions for domestic or international projects.
Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous
production
-related waste.
Determine the legal implications of the
production
, supply, or use of ozone-depleting substances or equipment containing such substances.
Direct the collection
and
preparation
of laboratory samples as requested by regulatory agencies.
Obtain clearances for the use of recycled plastics in
product
packaging.
Provide
pre
-, ongoing,
and
post-inspection follow-up assistance to governmental inspectors.
Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy,
and
clarity of
presentation.
Recommend adjudication of
product
complaints.
Review
product
promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations
and
policies.
4
Detailed Work Activities
Prepare
financial documents.
Prepare
regulatory or compliance documentation.
Examine
product
information to ensure compliance with regulations.
Investigate system, equipment, or
product
failures.
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Bright Outlook
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Industry
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STEM
All Occupations
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Job Duties
Professional Associations
Related Activities
Soft Skills
Technology Skills
O*NET Data
Abilities
Interests
Knowledge
Skills (Basic)
Skills (Cross-Functional)
Work Activities
Work Context
Work Styles
Work Values
Crosswalks
Military
Education
Occupation Handbook
SOC
DOT
RAPIDS
ESCO
Sites
My Next Move
Mi Próximo Paso
My Next Move for Veterans
Resource Center
O*NET Web Services
Code Connector
Partner sites
Data Collection Program
U.S. Department of Labor
Related Sites
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Creative Commons CC-BY
License
How do they match: 13-1041.07 - Regulatory Affairs Specialists
by
U.S. Department of Labor, Employment and Training Administration
is licensed under a
Creative Commons Attribution 4.0 International License
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