Will “Compliance Analyst” 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
- Clinical Quality Assurance Specialist
- Clinical Quality Assurance Associate
Tasks for “Compliance Analyst”
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Analyze product complaints and make recommendations regarding their reportability.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Compile and maintain regulatory documentation databases or systems.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Obtain clearances for the use of recycled plastics in product packaging.
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Participate in internal or external audits.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Monitor national or international legislation on ozone-depleting substances or global warming.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
- Write or update standard operating procedures, work instructions, or policies.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Develop or conduct employee regulatory training.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
- Develop or track quality metrics.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- Coordinate recall or market withdrawal activities as necessary.
Related Technology & Tools
- Computer data input scanners
- Desktop computers
- Personal computers
- Laser facsimile machines
- Multi-line telephone systems
- Photocopying equipment
- Laptop computers
- Microsoft Outlook
- Adobe Systems Adobe Acrobat
- MicroStrategy
- Microsoft Project
- Healthcare common procedure coding system HCPCS
- Fund accounting software
- Medical procedure coding software
- FileMaker Pro
- Microsoft Office
- Microsoft Word
- Qlik Tech QlikView
- Atrion Intelligent Authoring
- Structured query language SQL
- Human resource management software HRMS
- Analyse-it
- DataVision
- Microsoft Access
- Integrated development environment IDE software
- Microsoft PowerPoint
- Statistical software
- Microsoft Excel
- LexisNexis
- Web browser software
- SAP
- Microsoft SharePoint