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Summary Report for:
13-1041.07 - Regulatory Affairs Specialists

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.

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Tasks  |  Tools & Technology  |  Knowledge  |  Skills  |  Abilities  |  Work Activities  |  Work Context  |  Job Zone  |  Education  |  Credentials  |  Interests  |  Work Styles  |  Work Values  |  Related Occupations  |  Wages & Employment  |  Job Openings

Tasks

  • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

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Tools & Technology

Tools used in this occupation:

Laser fax machine — Laser facsimile machines
Notebook computers — Laptop computers
Photocopiers — Photocopying equipment
Scanners — Computer data input scanners
Special purpose telephones — Multi-line telephone systems

Technology used in this occupation:

Analytical or scientific software — Analyse-it Software; Statistical software
Data base user interface and query software — FileMaker Pro software; Microsoft Access
Document management software — Adobe Systems Adobe Acrobat software; Atrion Intelligent Authoring
Electronic mail software — Microsoft Outlook
Spreadsheet software — Microsoft Excel

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Knowledge

English Language — Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government — Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Clerical — Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.

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Skills

Reading Comprehension — Understanding written sentences and paragraphs in work related documents.
Critical Thinking — Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Writing — Communicating effectively in writing as appropriate for the needs of the audience.
Speaking — Talking to others to convey information effectively.
Active Listening — Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Complex Problem Solving — Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Judgment and Decision Making — Considering the relative costs and benefits of potential actions to choose the most appropriate one.
Systems Analysis — Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Active Learning — Understanding the implications of new information for both current and future problem-solving and decision-making.
Coordination — Adjusting actions in relation to others' actions.

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Abilities

Written Comprehension — The ability to read and understand information and ideas presented in writing.
Written Expression — The ability to communicate information and ideas in writing so others will understand.
Oral Comprehension — The ability to listen to and understand information and ideas presented through spoken words and sentences.
Oral Expression — The ability to communicate information and ideas in speaking so others will understand.
Problem Sensitivity — The ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem.
Deductive Reasoning — The ability to apply general rules to specific problems to produce answers that make sense.
Inductive Reasoning — The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Information Ordering — The ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules (e.g., patterns of numbers, letters, words, pictures, mathematical operations).
Near Vision — The ability to see details at close range (within a few feet of the observer).
Speech Clarity — The ability to speak clearly so others can understand you.

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Work Activities

Evaluating Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.
Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.
Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
Communicating with Persons Outside Organization — Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.

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Work Context

Electronic Mail — How often do you use electronic mail in this job?
Telephone — How often do you have telephone conversations in this job?
Face-to-Face Discussions — How often do you have to have face-to-face discussions with individuals or teams in this job?
Importance of Being Exact or Accurate — How important is being very exact or highly accurate in performing this job?
Spend Time Sitting — How much does this job require sitting?
Work With Work Group or Team — How important is it to work with others in a group or team in this job?
Structured versus Unstructured Work — To what extent is this job structured for the worker, rather than allowing the worker to determine tasks, priorities, and goals?
Indoors, Environmentally Controlled — How often does this job require working indoors in environmentally controlled conditions?
Duration of Typical Work Week — Number of hours typically worked in one week.
Contact With Others — How much does this job require the worker to be in contact with others (face-to-face, by telephone, or otherwise) in order to perform it?

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Job Zone

Title Job Zone Four: Considerable Preparation Needed
Education Most of these occupations require a four-year bachelor's degree, but some do not.
Related Experience A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
Job Training Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
Job Zone Examples Many of these occupations involve coordinating, supervising, managing, or training others. Examples include accountants, sales managers, database administrators, teachers, chemists, environmental engineers, criminal investigators, and special agents.
SVP Range (7.0 to < 8.0)

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Education


Percentage of Respondents
Education Level Required
78   Bachelor's degree
  Post-baccalaureate certificate Help
  Master's degree

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Credentials

Find Certifications Find Licenses

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Interests

Interest code: CE

Conventional — Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.
Enterprising — Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.

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Work Styles

Integrity — Job requires being honest and ethical.
Attention to Detail — Job requires being careful about detail and thorough in completing work tasks.
Dependability — Job requires being reliable, responsible, and dependable, and fulfilling obligations.
Adaptability/Flexibility — Job requires being open to change (positive or negative) and to considerable variety in the workplace.
Analytical Thinking — Job requires analyzing information and using logic to address work-related issues and problems.
Stress Tolerance — Job requires accepting criticism and dealing calmly and effectively with high stress situations.
Initiative — Job requires a willingness to take on responsibilities and challenges.
Persistence — Job requires persistence in the face of obstacles.
Cooperation — Job requires being pleasant with others on the job and displaying a good-natured, cooperative attitude.
Achievement/Effort — Job requires establishing and maintaining personally challenging achievement goals and exerting effort toward mastering tasks.

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Work Values

Working Conditions — Occupations that satisfy this work value offer job security and good working conditions. Corresponding needs are Activity, Compensation, Independence, Security, Variety and Working Conditions.
Independence — Occupations that satisfy this work value allow employees to work on their own and make decisions. Corresponding needs are Creativity, Responsibility and Autonomy.
Support — Occupations that satisfy this work value offer supportive management that stands behind employees. Corresponding needs are Company Policies, Supervision: Human Relations and Supervision: Technical.

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Related Occupations

11-9121.01 Clinical Research Coordinators Bright Outlook
11-9199.01 Regulatory Affairs Managers   Bright Outlook Bright Outlook     Green Occupation Green
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13-1081.02 Logistics Analysts Bright Outlook Green Occupation
13-1141.00 Compensation, Benefits, and Job Analysis Specialists
13-1161.00 Market Research Analysts and Marketing Specialists Bright Outlook
13-2011.02 Auditors Bright Outlook
13-2041.00 Credit Analysts
13-2053.00 Insurance Underwriters
13-2099.02 Risk Management Specialists Bright Outlook Green Occupation

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Wages & Employment Trends

Median wages data collected from Compliance Officers.
Employment data collected from Compliance Officers.
Industry data collected from Compliance Officers.

Median wages (2013) $30.93 hourly, $64,340 annual
State wages Local Salary Info
 
Employment (2012) 240,000 employees
Projected growth (2012-2022) Slower than average (3% to 7%) Slower than average (3% to 7%)
Projected job openings (2012-2022) 55,300
State trends Employment Trends
 
Top industries (2012)

Source: Bureau of Labor Statistics 2013 wage data external site and 2012-2022 employment projections external site. "Projected growth" represents the estimated change in total employment over the projections period (2012-2022). "Projected job openings" represent openings due to growth and replacement.

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Job Openings on the Web

Find Jobs Job Banks

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