Will “Clinical Quality Assurance Associate” be Replaced By Robots? 🤔
Unknown Chance of Automation
Sadly, the research paper did not provide any information about this occupation. Maybe have a look at our directory?
Job 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.
Job Details
- The SOC (Standard Occupational Classification) code is 13-1041.07
☝️ Information based on the reference occupation “Regulatory Affairs Specialists”.
Also Known As…
- Regulatory Affairs Specialists
- Regulatory Submissions Associate
- Regulatory Services Consultant
- Regulatory Associate
- Regulatory Affairs Strategy Specialist
- Regulatory Affairs Specialist
- Regulatory Affairs Consultant
- Regulatory Affairs Associate
- Regulatory Affairs Analyst
- Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist)
- Drug Regulatory Affairs Specialist
- Research Quality Assurance Specialist
- Research Quality Assurance Analyst
- Research Compliance Specialist
- Regulatory Specialist
- Regulatory Compliance Specialist
- Regulatory Analyst
- Regulatory Affairs Coordinator
- Quality Assurance Specialist
- Quality Assurance Documentation Specialist
- Quality Assurance Documentation Coordinator
- Product Safety Specialist
- Compliance Specialist
- Compliance Consultant
- Compliance Analyst
- Clinical Quality Assurance Specialist
Tasks for “Clinical Quality Assurance Associate”
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Develop or track quality metrics.
- Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Participate in internal or external audits.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Obtain clearances for the use of recycled plastics in product packaging.
- Compile and maintain regulatory documentation databases or systems.
- Coordinate recall or market withdrawal activities as necessary.
- Develop or conduct employee regulatory training.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Write or update standard operating procedures, work instructions, or policies.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance 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.
- 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.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Analyze product complaints and make recommendations regarding their reportability.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Related Technology & Tools
- Desktop computers
- Multi-line telephone systems
- Photocopying equipment
- Personal computers
- Computer data input scanners
- Laser facsimile machines
- Laptop computers
- Healthcare common procedure coding system HCPCS
- Human resource management software HRMS
- MicroStrategy
- Microsoft Access
- Microsoft Outlook
- Atrion Intelligent Authoring
- Medical procedure coding software
- SAP
- FileMaker Pro
- LexisNexis
- Analyse-it
- Qlik Tech QlikView
- Integrated development environment IDE software
- Microsoft SharePoint
- Structured query language SQL
- Statistical software
- Microsoft Project
- Microsoft Office
- Microsoft Word
- DataVision
- Adobe Systems Adobe Acrobat
- Web browser software
- Fund accounting software
- Microsoft Excel
- Microsoft PowerPoint