Typical Tasks
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
Coordinate efforts associated with the preparation of regulatory documents or submissions.
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
What kind of work is this?
Conventional
Organized, Procedural Work
Enterprising
Business based Work
Investigative
Studying, Research based work
What personality traits do you need to succeed?
Attention to Detail
Integrity
Dependability
Cooperation
Persistence
Analytical Thinking
What key skills are needed for this job?
Writing
Active Listening
Speaking
Judgment and Decision Making
Reading Comprehension
Critical Thinking
Expected 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.
Biology
Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Common 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.
Communicating with Supervisors, Peers, or Subordinates
Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
