Regulatory Affairs Specialist

2 weeks ago

Texas, United States Randstad Life Sciences US Full time
Regulatory Affairs Specialist

A global company, we work in over 70 countries and serve patients in more than 140 countries. We have a long history of industry firsts, and each year we commit a substantial amount in Research and Development to meet customer needs and patient demands. Our leadership is grounded in cutting-edge innovation and breakthrough technology, transforming the way we treat eye diseases and eye conditions.

Key Responsibilities:
  • Regulatory Documentation: Compile and maintain regulatory documentation databases or systems.
  • Regulatory Submissions: Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Product Complaints: Analyze product complaints and make recommendations regarding their reportability.
  • Employee Training: Develop or conduct employee regulatory training.
  • Regulatory Agency Communication: Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Inspections: Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Regulatory Submissions Coordination: Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Regulatory Rule Interpretation: Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Technical Review: Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Product Compliance: Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Project Support: Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Regulatory Submissions Determination: Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Regulatory Guidance: Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
  • Regulatory Knowledge: Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Regulatory Information Distribution: Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Audits: Participate in internal or external audits.
  • Regulatory Agency Responses: Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Technical Files: Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Procedure Updates: Recommend changes to company procedures in response to changes in regulations or standards.
  • Customer Information: Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Clinical Protocols: Review clinical protocols to ensure collection of data needed for regulatory submissions.
  • Standard Operating Procedures: Write or update standard operating procedures, work instructions, or policies.
  • Recall Activities: Coordinate recall or market withdrawal activities as necessary.
  • Quality Metrics: Develop or track quality metrics.
  • Sample Collection: Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Adverse Drug Reactions: Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
  • Waste Management: Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  • Hazardous Waste: Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Ozone-Depleting Substances: Monitor national or international legislation on ozone-depleting substances or global warming.
  • Recycled Plastics: Obtain clearances for the use of recycled plastics in product packaging.
  • Legal Requirements: Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Regulatory Issues: 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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