Regulatory Affairs Specialist

What You Need to Know About Regulatory Affairs Specialist

Example of Regulatory Affairs Specialist Job : 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.

Ensure you read the information regarding this opportunity thoroughly before making an application.

Regulatory Affairs Specialist Responsibilities

• Recommend changes to company procedures in response to changes in regulations or standards.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Coordinate, prepare, or review regulatory submissions for domestic or international projects.
• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

What Skills Do You Need to Work as a Regulatory Affairs Specialist?

Regulatory Affairs Specialists state the following job skills are important in their day-to-day work :

• 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.
• Writing : Communicating effectively in writing as appropriate for the needs of the audience.
• Speaking : Talking to others to convey information effectively.
• Reading Comprehension : Understanding written sentences and paragraphs in work-related documents.
• Judgment and Decision Making : Considering the relative costs and benefits of potential actions to choose the most appropriate one.
• Critical Thinking : Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.

Average Regulatory Affairs Specialists Salary

Regulatory Affairs Specialists make between $38,320 and $109,650 a year. Regulatory Affairs Specialists who work in District of Columbia, Alaska, or California , make the highest salaries.

What Tools do Regulatory Affairs Specialists Use?

Below is a list of the types of tools and technologies that Regulatory Affairs Specialists may use on a daily basis :

• Microsoft Excel
• Microsoft Word
• Microsoft Office
• Microsoft PowerPoint
• Microsoft Outlook
• Microsoft Access
• Microsoft Project
• Microsoft Visio
• Microsoft SharePoint
• Microsoft Dynamics
• FileMaker Pro
• Microsoft SQL Server
• LexisNexis
• Medical procedure coding software

Becoming a Regulatory Affairs Specialist

What kind of Regulatory Affairs Specialist requirements are there?

Where Regulatory Affairs Specialists Are Employed

The table below shows some of the most common industries where those employed in this career field work.

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