Temporary Regulatory Affairs Specialist

The Regulatory Affairs Specialist position will include coordinating and maintaining promotional and commercial material review processes by interacting with marketing and clinical training functional departments.

The Regulatory Affairs Specialist is responsible for supporting material review workflows, maintaining documentation and tracking systems, and ensuring timely communication between requestors and reviewers.

 

ESSENTIAL FUNCTIONS OF THE POSITION:

• Triage marketing and training material for regulatory review and compliance
• Coordinate review requests by gathering required information from internal stakeholders and routing materials to appropriate reviewers
• Track review activities, feedback, approvals, and changes using Excel and other documentation tools
• Assist with conducting weekly material review meetings
• Assist with promotional and commercial material storage and document maintenance
• Prepare and distribute communications regarding review status, requests, and required follow-up actions
• Support electronic documentation and signature processes using approved company systems
• Independently manage day-to-day tasks

 

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions and manage changing priorities
• Ability to successfully work with others
• Strong attention to detail and organizational skills
• Ability to communicate effectively with cross-functional teams

 

BASIC QUALIFICATIONS:

• Computer and data entry skills
• Proficiency with Microsoft Excel and other Microsoft Office applications
• Written and verbal communication skills
• Strong organizational and documentation skills
• Ability to manage multiple tasks and maintain accurate records

 

PREFERRED QUALIFICATIONS:

• Previous experience in an administrative, coordinator, data entry, documentation, or support role
• Experience using electronic signature platforms (Adobe Acrobat Sign, DocuSign, or similar)
• Experience supporting review, approval, or workflow processes
• Experience in a regulated industry, medical device industry, or medical environment
• Familiarity with Microsoft Forms

 

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to pass pre-employment drug screen and background check
  
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