Regulatory Affairs Specialist

Advantage Technical
$42.00-$42.00
life insurance, 401(k)
United States, Texas, Dallas
14875 Landmark Boulevard (Show on map)
May 29, 2026
Advantage Technical is partnering with a leading medical device manufacturer to place a Regulatory Affairs Specialist in a 12-month remote contract role with extension potential. This role begins with structured training on internal systems and processes, followed by regulatory submission archiving to address existing backlog, with a gradual transition into full RA responsibilities. What You'll Do (Job Duties) Archive and manage regulatory submissions using regulatory management systems Prepare and submit regulatory applications; maintain internal regulatory documentation Support regulatory strategy development for new and modified medical devices Review device labeling and advertising materials for compliance Review product and manufacturing changes for applicable regulatory compliance Serve as core team member throughout the product development cycle What You Bring (Skills, Requirements and Qualifications) BS + 2-4 years RA experience, or MS + 0-2 years (required) Demonstrated regulatory affairs background - required Experience with regulatory management systems for submission archiving Proficiency in Microsoft Office; Windchill a plus Strong written and verbal communication skills Able to work independently with minimal supervision Dedicated home office with reliable internet Must be authorized to work in the U.S. - no visa sponsorship available now or in the future Candidates with medical writing backgrounds will not be considered Advantage Technical Benefits Weekly pay: $42.00/hour Weekly direct deposit Medical, dental, vision, and life insurance Optional 401(k) Apply now and an Advantage Technical recruiter will contact you soon! About Us Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.