Regulatory Affairs Specialists

Recruiter.com helps professionals in regulatory affairs specialist careers find better opportunities across all specialties and locations.





Also known as:  Air Pollution Compliance Inspector, Compliance Investigator, Driver's License Examiner, EEO Officer, Environmental Compliance Inspector, Equal Employment Opportunity Investigator, Equal Employment Opportunity Officer, Equal Employment Opportunity Representative, Immigration Investigator, Inspector of Weights and Measures
SNAPSHOT Expand
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.
Leadership
HIGH
Critical decision making
HIGH
Level of responsibilities
LOW
Job challenge and pressure to meet deadlines
HIGH
Dealing and handling conflict
LOW
Competition for this position
MED
Communication with others
HIGH
Work closely with team members, clients etc.
HIGH
Comfort of the work setting
HIGH
Exposure to extreme environmental conditions
LOW
Exposure to job hazards
LOW
Physical demands
LOW
Want to pursue a career as Regulatory Affairs Specialist? Create a job alert, and get new job listings in your area sent directly to you.
DAILY TASKS Expand
Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
Participate in internal or external audits.
Develop or conduct employee regulatory training.
Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
Recommend changes to company procedures in response to changes in regulations or standards.
Review clinical protocols to ensure collection of data needed for regulatory submissions.
Write or update standard operating procedures, work instructions, or policies.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
MAIN ACTIVITIES Expand
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.
Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
AREAS OF KNOWLEDGE Expand
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.
Computers and Electronics Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
Administration and Management Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
Medicine and Dentistry Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
Mathematics Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
Biology Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
KEY ABILITIES Expand
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.
Inductive Reasoning The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events).
Deductive Reasoning The ability to apply general rules to specific problems to produce answers that make sense.
Speech Clarity The ability to speak clearly so others can understand you.
TOP SKILLS Expand
Reading Comprehension Understanding written sentences and paragraphs in work related documents.
Writing Communicating effectively in writing as appropriate for the needs of the audience.
Critical Thinking Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Speaking Talking to others to convey information effectively.
Complex Problem Solving Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Systems Analysis Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
Judgment and Decision Making Considering the relative costs and benefits of potential actions to choose the most appropriate one.
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.
There is a better job out there!
Post your resume to the largest network of recruiters on the planet. START