Any company that manufactures products or conducts testing that affects humans, animals or plants is usually regulated by federal government through either the FDA, USDA or EPA and sometimes by multiple agencies. Most of the companies previously listed fall into one or more of these categories. In addition, clinical research companies will also fall under these guidelines (primarily FDA). So it is important that accurate and current records are maintained by the company to ensure that all procedures are being followed according to the regulations that govern the particular part of the industry. There are companies dedicated to helping others navigate through the regulatory jungle – one such company is Beckloff Associates (Overland Park).

Regulatory Affairs Specialist

A regulatory affairs specialist, at the entry level, coordinates and prepares document packages for submission to regulatory agencies, internal audits and inspections. He or she compiles all material required for submissions, license renewals and annual registrations. An incumbent monitors and improves tracking and control systems and keeps abreast of regulatory procedures and changes. He or she may work with regulatory agencies and recommend strategies for earliest possible approvals of clinical trial applications. An entry-level position requires a bachelor of science degree or equivalent and a minimum of zero to two years related experience.

Documentation Coordinator

A documentation coordinator provides clerical and administrative support related to a company’s documentation system requirements. He or she audits all documentation manuals to ensure that they are accurate, up-to-date and available to appropriate personnel. A documentation coordinator also files and retrieves all master documents. The position requires a high school diploma or equivalent and a minimum of zero to two years related experience.

Documentation Specialist

An entry-level documentation specialist is responsible for coordinating all activities related to providing required documentation and implementing related documentation systems. He or she coordinates the review and revision of procedures, specifications and forms. He or she also assists in compiling regulatory filing documents and in maintaining computerized files to support all documentation systems. The job requires a bachelor of science degree in a related field or equivalent and a minimum of zero to two years experience in documentation, quality assurance, technical writing or the equivalent.