REGULATORY AFFAIRS SPECIALIST
Company: Source One Technical Solutions
Location: Lake Forest
Posted on: October 30, 2024
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Job Description:
Source One is a consulting services company and we're currently
looking for the following individual to work as a consultant to our
direct client, a global medical device company in Lake Forest,
CA.
Title: Regulatory Affairs Specialist - ContractorPay Rate:
$58.79/hr (W-2)
Job Description:- Compile and maintain regulatory documentation
databases or systems.- Coordinate efforts associated with the
preparation of regulatory documents or submissions.- Analyze
product complaints and make recommendations regarding their
reportability.- Develop or conduct employee regulatory training.-
Communicate with regulatory agencies regarding pre-submission
strategies, potential regulatory pathways, compliance test
requirements, or clarification and follow-up of submissions under
review.- Escort government inspectors during inspections and
provide post-inspection follow-up information as requested.-
Coordinate, prepare, or review regulatory submissions for domestic
or international projects.- Interpret regulatory rules or rule
changes and ensure that they are communicated through corporate
policies and procedures.- Provide technical review of data or
reports that will be incorporated into regulatory submissions to
assure scientific rigor, accuracy, and clarity of presentation.-
Review product promotional materials, labeling, batch records,
specification sheets, or test methods for compliance with
applicable regulations and policies.- Advise project teams on
subjects such as premarket regulatory requirements, export and
labeling requirements, or clinical study compliance issues.-
Determine the types of regulatory submissions or internal
documentation that are required in situations such as proposed
device changes or labeling changes.- Identify relevant guidance
documents, international standards, or consensus standards and
provide interpretive assistance.- Maintain a current knowledge base
of existing and emerging regulations, standards, or guidance
documents.- Obtain and distribute updated information regarding
domestic or international laws, guidelines, or standards.-
Participate in internal or external audits.- 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.- Recommend
changes to company procedures in response to changes in regulations
or standards.- Prepare responses to customer requests for
information, such as product data, written regulatory affairs
statements, surveys, or questionnaires.- Review clinical protocols
to ensure collection of data needed for regulatory submissions.-
Write or update standard operating procedures, work instructions,
or policies.- Coordinate recall or market withdrawal activities as
necessary.- Develop or track quality metrics.- Direct the
collection and preparation of laboratory samples as requested by
regulatory agencies.- Review adverse drug reactions and file all
related reports in accordance with regulatory agency guidelines.-
Determine regulations or procedures related to the management,
collection, reuse, recovery, or recycling of packaging waste.-
Determine requirements applying to treatment, storage, shipment, or
disposal of potentially hazardous production-related waste.-
Monitor national or international legislation on ozone-depleting
substances or global warming.- Obtain clearances for the use of
recycled plastics in product packaging.- Determine the effects of
legal requirements related to the production, supply, or use of
ozone-depleting substances or equipment containing such
substances.- Specialize in regulatory issues related to
agriculture, such as the cultivation of green biotechnology crops
or the post-market regulation of genetically altered crops.
Requirements:- Bachelor's degree- At least 3 years of work
experience- Knowledge of US, EU, and Canada Medical Device
Regulations- Familiarity with PLM WindChill and Veeva RIM platforms
(not a mandatory requirement)
Keywords: Source One Technical Solutions, Redlands , REGULATORY AFFAIRS SPECIALIST, Other , Lake Forest, California
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