Regulatory Affairs Specialist

4 weeks ago

Lake Forest, California, United States Randstad Full time

Job Summary:

Randstad is seeking a highly skilled Regulatory Affairs Specialist II to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines.

Key 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 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.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • 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.
  • 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.
  • 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 (BS / BA)
  • Three (3) to five (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)

Equal Opportunity Employer:

Randstad is an equal opportunity employer and welcomes applications from all qualified candidates.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

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