Randstad USA is hiring: Part-Time Regulatory Affairs Consultant, Ad/Promo in Ral

Part-Time Regulatory Affairs Consultant, Ad/Promo We are seeking a Part-Time Regulatory Affairs Consultant, Ad/Promo Compliance to support our Regulatory Affairs team, working approximately 20 hours per week (preferred Tuesday-Thursday during North Carolina HQ business hours). This specialized role focuses on Advertising and Promotional Regulatory Affairs. Location: Raleigh, North Carolina Job type: Contract Salary: $80 - 83 per hour Work hours: 8 to 4 Education: Bachelors Responsibilities Lead Promotional Review Committee (PRC) Activities: Serve as the core Regulatory representative on the PRC, responsible for the thorough review and final approval of all proposed advertising, promotion, and scientific materials for multiple product lines. Ensure Dual Regulatory Compliance: Maintain strict compliance by applying a robust working knowledge of promotional regulations governed by both EU MDR and FDA for all assigned materials and claims. Provide Strategic Claims Guidance: Deliver proactive regulatory expertise and risk assessments on proposed product claims, including the development of Important Safety Information (ISI) and Brief Summaries for products in development and launch. Support Product Lifecycle and Launch: Collaborate closely with R&D, Marketing, and project teams to advise on labeling and ensure all new product and indication launch materials meet regulatory requirements prior to market release. Manage Regulatory Submissions & Documentation: Oversee the timely and accurate submission of promotional materials to health authorities as needed, and maintain comprehensive documentation and processes necessary to support internal and external audits. Monitor Market and Compliance Trends: Proactively monitor evolving EU MDR and FDA regulations, guidance, and enforcement actions, while regularly analyzing competitor materials to inform internal market messaging and compliance strategy within the aesthetic industry. Qualifications 5+ years’ experience reviewing all scientific information, advertising, and promotional materials for assigned products. 3+ years of direct experience reviewing advertising, promotion, and labeling materials for drugs and medical devices to ensure compliance with both EU MDR and FDA regulations and guidance. Preferred Master’s degree or higher in the above field is highly desirable. Skills Product Marketing, Regulatory Submission Compliance, FDA Submissions, Medical Device Regulation (MDR) Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. Contact If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Posting is open for thirty (30) days. #J-18808-Ljbffr