Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Summary This position is in the Department of Veterans Affairs (VA), Mid-South Healthcare Network (VISN 9), Memphis VA Medical Center (VAMC) Emergency Medicine.
The incumbent reports directly to the AO / higher ranking administrative official or Chief of Service and is responsible for providing support to the Chief of Service and Section Chiefs within the service, which includes analytical support and management services essential to the direction of the organization.
Responsibilities The incumbent serves as a focal resource person responsible for providing administrative coordination in the development, implementation, evaluation, interpretation, revision, and necessary corrective action of all applicable administrative policies.
Research and / or analyzes problems, issues, or program requirements. Research and / or analyzes stable issues which may be simple or complex in nature.
Determines pertinent issues and collects relevant information from a variety of sources. Reviews information and applies standard analytical techniques.
Develops recommendations and proposals based on research. Major duties for the Program Specialist include but are not limited to) : Incumbent conducts special projects as assigned.
Special projects generally involve fact-finding, data analysis, benchmarking, networking within and outside of the facility and presenting formalized suggestions for problem resolution as well as assisting with the development and implementation of new or reviewed policies or program changes.
Projects include, but are not limited to : identifying, understanding and planning for organizational and human impacts of planned systems, and ensuring that new systems requirements are properly integrated with existing processes and skill sets;
to formulate sustainable future processes; writing or assisting with writing technical requirements of critical and noncritical phases of the process, and assisting teams in using flow charts and with developing an associated implementation / action plan.
Position interacts with customers to understand limitations, needs, requirements, etc. Independently researches, collects, organizes, and displays data related to assigned initiatives and projects, preparing reports in various formats such as word, PowerPoint and excel that enable users to identify potential issues, needs and opportunities for improvement related to initiatives.
Designs and develops spreadsheets for the Performance Improvement Team, Systems Redesign Coordinator, Performance Improvement Committees, and others as indicated for display on the visual huddle boards and interpretation of data, interpretation of data elements and / or other information contained in reports.
Collects data and interprets, trends data and develops action plans for improvement for metrics such as SAIL, AES, IPEC, NSO, HRO, etc.
Assures that reports and documents are accurate, professionally written and structured in a user-friendly format and communicated in a timely manner.
Conducts extensive research and compilation of data from diverse sources. Extracts and assembles information, conducts analysis, and develops reports or presentations.
Identifies and determines training priorities, conducts and administers training programs, develops and improves training guidance.
Performs other duties as assigned. Promotion Potential : The selectee may be promoted to the full performance level without further competition when all regulatory, qualification, and performance requirements are met.
Selection at a lower grade level does not guarantee promotion to the full performance level. Work Schedule : Monday thru Friday 8 : 00am-4 : 30pm Telework : Not Authorized Virtual : This is not a virtual position.
Position Description / PD# : Program Specialist / PD50485A Relocation / Recruitment Incentives : Not Authorized Permanent Change of Station (PCS) : Not Authorized Financial Disclosure Report : Not required Requirements Conditions of Employment You must be a U.
S. Citizen to apply for this job Selective Service Registration is required for males born after 12 / 31 / 1959 You may be required to serve a probationary period Subject to background / security investigation Selected applicants will be required to complete an online onboarding process Participation in the seasonal influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Qualifications To qualify for this position, applicants must meet all requirements by the closing date of this announcement, 03 / 04 / 2024.
Time-In-Grade Requirement : Applicants who are current Federal employees and have held a GS grade any time in the past 52 weeks must also meet time-in-grade requirements by the closing date of this announcement .
For a GS-09 position you must have served 52 weeks at the GS-07. For a GS-11 position you must have served 52 weeks at the GS-09.
The grade may have been in any occupation, but must have been held in the Federal service. An SF-50 that shows your time-in-grade eligibility must be submitted with your application materials.
If the most recent SF-50 has an effective date within the past year, it may not clearly demonstrate you possess one-year time-in-grade, as required by the announcement.
In this instance, you must provide an additional SF-50 that clearly demonstrates one-year time-in-grade. You may qualify based on your experience and / or education as described below : Specialized Experience GS-09 : You must have one year of specialized experience equivalent to at least the next lower grade GS-07 in the normal line of progression for the occupation in the organization.
Examples of specialized experience would typically include, but are not limited to : Knowledge of health care systems and delivery systems, management principles, practices, methods and techniques, and skill in integrating management services with general management of the organization is needed.
Applies knowledge and abilities to analyze, evaluate and make recommendations on major aspects of all assigned VISTA and commercial off the shelf computer packages.
Incumbent works with OI&T to troubleshooting computer packages, which require developing specifications and business process models.
Ability to retrieve, track and trend information for analysis and reporting. Management analysis techniques and methods are needed to develop and refine information for comprehensive reports, addressing elements such as cost analysis, work measurement, trend analysis, efficiency, effectiveness, productivity, and assess the success or failure in attaining program goals / objectives.
Knowledge of the service software is required to train employees, identify inconsistencies, discuss with management the capabilities of software feasibility toward meeting objectives, validate new programs / options, recommend changes in existing programs and modify programs to meet future needs.
A comprehensive knowledge of software programs of other services (i.e. Radiology, Dietetics, Health Summary, OE / RR, CPRS, Laboratory and Pharmacy) is needed due to the interrelation of the VISTA programs to train staff.
Knowledge of, and skill in applying user acceptance testing principles, methods, and approaches sufficient to test, debug and maintain software applications that meet functional requirements.
OR, Education : Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have you must have a related Master degree or 2 full years of progressively higher level graduate education leading to such a degree or LLB.
or J.D., if related. (Transcripts Required) OR, Combination : Equivalent combination of successfully completed education and specialized experience directly related to the work of the position as outlined above that meets the requirements of the position.
Only education in excess of the first year (18 semester hours) may be used to qualify applicants for the GS-09 level. NOTE : If using education combined with specialized experience to qualify, a copy of your transcript is required.
Specialized Experience GS-11 : You must have one year of specialized experience equivalent to at least the next lower grade GS-09 in the normal line of progression for the occupation in the organization.
Examples of specialized experience would typically include but are not limited to : Knowledge of health care systems and delivery systems, management principles, practices, methods and techniques, and skill in integrating management services with general management of the organization is needed.
Applies knowledge and abilities to analyze, evaluate and make recommendations on major aspects of all assigned VISTA and commercial off the shelf computer packages.
Incumbent works with OI&T to troubleshooting computer packages, which require developing specifications and business process models.
Ability to retrieve, track and trend information for analysis and reporting. Management analysis techniques and methods are needed to develop and refine information for comprehensive reports, addressing elements such as cost analysis, work measurement, trend analysis, efficiency, effectiveness, productivity, and assess the success or failure in attaining program goals / objectives.
Knowledge of the service software is required to train employees, identify inconsistencies, discuss with management the capabilities of software feasibility toward meeting objectives, validate new programs / options, recommend changes in existing programs and modify programs to meet future needs.
A comprehensive knowledge of software programs of other services (i.e. Radiology, Dietetics, Health Summary, OE / RR, CPRS, Laboratory and Pharmacy) is needed due to the interrelation of the VISTA programs to train staff.
Knowledge of, and skill in applying user acceptance testing principles, methods, and approaches sufficient to test, debug and maintain software applications that meet functional requirements.
Possess an expert degree of knowledge of Patient Information Management System (PIMS) software to create entry transactions on simple data needs and provide reports about any of the clinical or administrative data elements contained in the PIMS package.
OR, Education : Applicants may substitute education for the required experience. To qualify based on education for this grade level you must have a Ph.
D. or equivalent doctoral degree, or, 3 full years of progressively higher-level graduate education leading to such a degree, or, LL.
M., if related to knowledge, skills, and abilities of the position. (Transcripts Required) OR, Combination : Applicants may also combine education and experience to qualify at this level.
You must have an combination of specialized experience and education beyond a master's degree. NOTE : If using education combined with specialized experience to qualify, a copy of your transcript is required.
You will be rated on the following Competencies for this position : Administration and Management Analytical Reasoning Contracting / Procurement Experience refers to paid and unpaid experience, including volunteer work done through National Service programs (e.
g., Peace Corps, AmeriCorps) and other organizations (e.g., professional; philanthropic; religions; spiritual; community;
student; social). Volunteer work helps build critical competencies, knowledge, and skills and can provide valuable training and experience that translates directly to paid employment.
You will receive credit for all qualifying experience, including volunteer experience. Note : A full year of work is considered to be 35-40 hours of work per week.
Part-time experience will be credited on the basis of time actually spent in appropriate activities. Applicants wishing to receive credit for such experience must indicate clearly the nature of their duties and responsibilities in each position and the number of hours a week spent in such employment.
Physical Requirements : Regular and recurring work is mostly sedentary involving sitting at a desk. However, some slight physical effort may be required.
For more information on these qualification standards, please visit the United States Office of Personnel Management's website at Education A transcript must be submitted with your application if you are basing all or part of your qualifications on education.
Note : Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment.
You can verify your education here : If you are using foreign education to meet qualification requirements, you must send a Certificate of Foreign Equivalency with your transcript in order to receive credit for that education.
For further information, visit : Additional Information Receiving Service Credit or Earning Annual (Vacation) Leave : Federal Employees earn annual leave at a rate (4, 6 or 8 hours per pay period) which is based on the number of years they have served as a Federal employee.
Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience.
This credited service can be used in determining the rate at which they earn annual leave. Such credit must be requested and approved prior to the appointment date and is not guaranteed.
This job opportunity announcement may be used to fill additional vacancies. If you are unable to apply online or need an alternate method to submit documents, please reach out to the Agency Contact listed in this Job Opportunity Announcement.
Last updated : 2024-02-24
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