Regulatory Affairs Specialist

4 days ago

Irvine, United States TalentBurst, an Inc 5000 company Full time

Position: Regulatory Affairs Specialist II, Req#: 3386-1

Location: Lake Forrest, CA (100% onsite)

Duration: 6+ Months Contract


Job Description:


Education and Experience:

  • Bachelor's degree
  • 3-5 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)


Roles and Responsibilities:

  • 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 the 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 the 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.

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