- Analyze new legislation to determine impact on risk exposure.
Occupations with related tasks Save Table: XLSX CSV
- 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.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- 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 direct the preparation of additional information or responses as requested by regulatory agencies.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Coordinate recall or market withdrawal activities as necessary.
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
- Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
- 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.
- Compile and maintain regulatory documentation databases or systems.
- Write or update standard operating procedures, work instructions, or policies.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
- Develop or track quality metrics.
- Develop or conduct employee regulatory training.
- Recommend adjudication of product complaints.
- Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
- 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 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.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
- Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
- Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
- Evaluate fire department performance and the laws and regulations affecting fire prevention or fire safety.
- Advise architects, builders, and other construction personnel on fire prevention equipment and techniques and on fire code and standard interpretation and compliance.
- Inspect buildings or building designs to determine fire protection system requirements and potential problems in areas such as water supplies, exit locations, and construction materials.
- Design fire detection equipment, alarm systems, and fire extinguishing devices and systems.
- Prepare and write reports detailing specific fire prevention and protection issues, such as work performed, revised codes or standards, and proposed review schedules.
- Consult with authorities to discuss safety regulations and to recommend changes as necessary.
- Direct the purchase, modification, installation, testing, maintenance, and operation of fire prevention and protection systems.
- Determine causes of fires and ways in which they could have been prevented.
- Develop plans for the prevention of destruction by fire, wind, and water.
- Develop training materials and conduct training sessions on fire protection.
- Attend workshops, seminars, or conferences to present or obtain information regarding fire prevention and protection.
- Study the relationships between ignition sources and materials to determine how fires start.
- Conduct research on fire retardants and the fire safety of materials and devices.
- Evaluate fire department performance and the laws and regulations affecting fire prevention or fire safety.
- Monitor changes in legislation and accreditation standards that affect information security or privacy in the computerized healthcare system.
- Assign the patient to diagnosis-related groups (DRGs), using appropriate computer software.
- Compile medical care and census data for statistical reports on diseases treated, surgery performed, or use of hospital beds.
- Design databases to support healthcare applications, ensuring security, performance and reliability.
- Develop in-service educational materials.
- Evaluate and recommend upgrades or improvements to existing computerized healthcare systems.
- Facilitate and promote activities, such as lunches, seminars, or tours, to foster healthcare information privacy or security awareness within the organization.
- Identify, compile, abstract, and code patient data, using standard classification systems.
- Manage the department or supervise clerical workers, directing or controlling activities of personnel in the medical records department.
- Plan, develop, maintain, or operate a variety of health record indexes or storage and retrieval systems to collect, classify, store, or analyze information.
- Prepare statistical reports, narrative reports, or graphic presentations of information, such as tumor registry data for use by hospital staff, researchers, or other users.
- Protect the security of medical records to ensure that confidentiality is maintained.
- Resolve or clarify codes or diagnoses with conflicting, missing, or unclear information by consulting with doctors or others or by participating in the coding team's regular meetings.
- Retrieve patient medical records for physicians, technicians, or other medical personnel.
- Train medical records staff.
- Write or maintain archived procedures, procedural codes, or queries for applications.
- Monitor changes in legislation and accreditation standards that affect information security or privacy in the computerized healthcare system.
- Review and analyze new, proposed, or revised laws, regulations, policies, and procedures to interpret their meaning and determine their impact.
- Direct and participate in formal and informal meetings with bank directors, trustees, senior management, counsels, outside accountants, and consultants to gather information and discuss findings.
- Recommend actions to ensure compliance with laws and regulations, or to protect solvency of institutions.
- Prepare reports, exhibits, and other supporting schedules that detail an institution's safety and soundness, compliance with laws and regulations, and recommended solutions to questionable financial conditions.
- Resolve problems concerning the overall financial integrity of banking institutions including loan investment portfolios, capital, earnings, and specific or large troubled accounts.
- Investigate activities of institutions to enforce laws and regulations and to ensure legality of transactions and operations or financial solvency.
- Review balance sheets, operating income and expense accounts, and loan documentation to confirm institution assets and liabilities.
- Plan, supervise, and review work of assigned subordinates.
- Review audit reports of internal and external auditors to monitor adequacy of scope of reports or to discover specific weaknesses in internal routines.
- Examine the minutes of meetings of directors, stockholders, and committees to investigate the specific authority extended at various levels of management.
- Train other examiners in the financial examination process.
- Establish guidelines for procedures and policies that comply with new and revised regulations and direct their implementation.
- Provide regulatory compliance training to employees.
- Evaluate data processing applications for institutions under examination to develop recommendations for coordinating existing systems with examination procedures.
- Review applications for mergers, acquisitions, establishment of new institutions, acceptance in Federal Reserve System, or registration of securities sales to determine their public interest value and conformance to regulations, and recommend acceptance or rejection.
- Verify and inspect cash reserves, assigned collateral, and bank-owned securities to check internal control procedures.
- Confer with officials of real estate, securities, or financial institution industries to exchange views and discuss issues or pending cases.
- Review and analyze new, proposed, or revised laws, regulations, policies, and procedures to interpret their meaning and determine their impact.
- Monitor and follow applicable laws and regulations.
- Prepare purchase orders, solicit bid proposals, and review requisitions for goods and services.
- Negotiate, renegotiate, and administer contracts with suppliers, vendors, and other representatives.
- Purchase the highest quality merchandise at the lowest possible price and in correct amounts.
- Analyze price proposals, financial reports, and other data and information to determine reasonable prices.
- Formulate policies and procedures for bid proposals and procurement of goods and services.
- Hire, train, or supervise purchasing clerks, buyers, and expediters.
- Maintain and review computerized or manual records of purchased items, costs, deliveries, product performance, and inventories.
- Research and evaluate suppliers, based on price, quality, selection, service, support, availability, reliability, production and distribution capabilities, and the supplier's reputation and history.
- Confer with staff, users, and vendors to discuss defective or unacceptable goods or services and determine corrective action.
- Evaluate and monitor contract performance to ensure compliance with contractual obligations and to determine need for changes.
- Monitor shipments to ensure that goods come in on time, and resolve problems related to undelivered goods.
- Study sales records and inventory levels of current stock to develop strategic purchasing programs that facilitate employee access to supplies.
- Write and review product specifications, maintaining a working technical knowledge of the goods or services to be purchased.
- Review catalogs, industry periodicals, directories, trade journals, and Internet sites and consult with other department personnel to locate necessary goods and services.
- Monitor changes affecting supply and demand, tracking market conditions, price trends, or futures markets.
- Interview vendors and visit suppliers' plants and distribution centers to examine and learn about products, services, and prices.
- Arrange the payment of duty and freight charges.
- Attend meetings, trade shows, conferences, conventions, and seminars to network with people in other purchasing departments.
- Monitor and follow applicable laws and regulations.
- Interpret government regulations and applicable codes to ensure compliance.
- Develop emergency management plans for recovery decision making and communications, continuity of critical departmental processes, or temporary shut-down of non-critical departments to ensure continuity of operation and governance.
- Develop disaster recovery plans for physical locations with critical assets, such as data centers.
- Test documented disaster recovery strategies and plans.
- Analyze impact on, and risk to, essential business functions or information systems to identify acceptable recovery time periods and resource requirements.
- Write reports to summarize testing activities, including descriptions of goals, planning, scheduling, execution, results, analysis, conclusions, and recommendations.
- Review existing disaster recovery, crisis management, or business continuity plans.
- Create scenarios to reestablish operations from various types of business disruptions.
- Establish, maintain, or test call trees to ensure appropriate communication during disaster.
- Conduct or oversee contingency plan integration and operation.
- Identify opportunities for strategic improvement or mitigation of business interruption and other risks caused by business, regulatory, or industry-specific change initiatives.
- Create or administer training and awareness presentations or materials.
- Prepare reports summarizing operational results, financial performance, or accomplishments of specified objectives, goals, or plans.
- Attend professional meetings, read literature, and participate in training or other educational offerings to keep abreast of new developments and technologies related to disaster recovery and business continuity.
- Recommend or implement methods to monitor, evaluate, or enable resolution of safety, operations, or compliance interruptions.
- Create business continuity and disaster recovery budgets.
- Maintain and update organization information technology applications and network systems blueprints.
- Design or implement products and services to mitigate risk or facilitate use of technology-based tools and methods.
- Analyze corporate intelligence data to identify trends, patterns, or warnings indicating threats to security of people, assets, information, or infrastructure.
- Conduct or oversee collection of corporate intelligence to avoid fraud, financial crime, cyber attack, terrorism, and infrastructure failure.
- Identify individual or transaction targets to direct intelligence collection.
- Interpret government regulations and applicable codes to ensure compliance.
