[Remote] Part-Time Regulatory Affairs Consultant, Ad/Promo

Note: The job is a remote job and is open to candidates in USA. Randstad USA is seeking a Part-Time Regulatory Affairs Consultant focused on Advertising and Promotional Regulatory Affairs. This role will involve reviewing scientific information and promotional materials to ensure compliance with regulations, while collaborating with various teams to support product lifecycle and launch. 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 (drugs, devices, and combination products) • Ensure Dual Regulatory Compliance: Maintain strict compliance by applying a robust working knowledge of promotional regulations governed by both EU MDR (European Medical Device Regulation) and the 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 Skills • 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 • Master's degree or higher in the above field is highly desirable Benefits • Medical • Prescription • Dental • Vision • AD&D • Life insurance offerings • Short-term disability • 401K plan Company Overview • Randstad US is a wholly owned subsidiary of Randstad Holding nv, a global provider of human resources solutions. It was founded in 1998, and is headquartered in Atlanta, Georgia, USA, with a workforce of 1001-5000 employees. Its website is Company H1B Sponsorship • Randstad USA has a track record of offering H1B sponsorships, with 754 in 2023, 776 in 2022, 1143 in 2021, 1749 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job