Regulatory Affairs Specialists

Course Advisor, Inc.; United States; On-site; USD 70,000 - 100,000; Full time

Job summary

Course Advisor is seeking a Regulatory Affairs Specialist to coordinate and document internal regulatory processes such as audits and license renewals. Responsibilities include recommending changes to procedures based on regulations, advising project teams on compliance, and preparing regulatory submissions. The role requires strong skills in active listening, writing, and critical thinking. Proficiency in tools like Microsoft Excel, Word, and SAP is preferred. This position is located in the United States and offers opportunities for professional growth.

Responsibilities

• Recommend changes to company procedures in response to changes in regulations or standards.
• Prepare additional information or responses as requested by regulatory agencies.
• Advise project teams on regulatory requirements and compliance issues.
• Provide technical review of reports for regulatory submissions.
• Coordinate regulatory submissions for projects.
• Interpret and communicate regulatory rules and changes.

Skills

Active Listening

Writing

Speaking

Reading Comprehension

Judgment and Decision Making

Critical Thinking

Tools

Microsoft Excel

Microsoft Word

Microsoft Office

Microsoft PowerPoint

Microsoft Outlook

Web browser software

Microsoft Access

SAP

Microsoft Project

Adobe Acrobat

Microsoft Visio

Microsoft SharePoint

SQL

Microsoft Dynamics

FileMaker Pro

Microsoft SQL Server

LexisNexis

Medical procedure coding software

MicroStrategy

QlikView

Job description

Regulatory Affairs Specialist

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.

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.

Skills

• 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.

Other Regulatory Affairs Specialist Job Titles

• Quality Assurance Documentation Specialist
• Regulatory Affairs Specialist
• Regulatory Affairs Associate
• Regulatory Affairs Strategy Specialist
• Compliance Analyst

Tools

• Microsoft Excel
• Microsoft Word
• Microsoft Office
• Microsoft PowerPoint
• Microsoft Outlook
• Web browser software
• Microsoft Access
• SAP
• Microsoft Project
• Adobe Acrobat
• Microsoft Visio
• Microsoft SharePoint
• SQL
• Microsoft Dynamics
• FileMaker Pro
• Microsoft SQL Server
• LexisNexis
• Medical procedure coding software
• MicroStrategy
• QlikView