Occupation information for Regulatory Affairs Specialists District Of Columbia

See Job Listings (37) Find Businesses

Typical education needed for entry: Bachelor's degree

Typical work experience needed for a job in this occupation: No work experience

Typical on-the-job training once you have a job in this occupation: 1 to 12 months on-the-job training

Find Training

• Coordinate efforts associated with the preparation of regulatory documents or submissions.
• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Prepare or maintain technical files as necessary to obtain and sustain product approval.
• 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.
• Coordinate recall or market withdrawal activities as necessary.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

Tools:

• Desktop computers
• Laser fax machine
• Notebook computers
• Personal computers
• Photocopiers

Technology:

• Accounting software
• Analytical or scientific software
• Business intelligence and data analysis software
• Data base user interface and query software
• Development environment software

Explore Careers

Salary Info

Resumes + Applications

Employer Research