Part-Time Regulatory Affairs Consultant, Ad/Promo

job summary: 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 role is fully remote, with no travel. This specialized role focuses on Advertising and Promotional Regulatory Affairs. The consultant will serve as the Regulatory representative on the Promotional Review Committee providing crucial strategic expertise and guidance to stakeholders. The core responsibility is to review all scientific information, advertising, and promotional materials for assigned products to ensure strict compliance with applicable regulations. Candidates must possess a thorough working knowledge of promotional compliance regulations governing drugs, medical devices, and combination products, and have direct experience reviewing materials subject to both EU MDR and FDA requirements 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 (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. qualifications: Required:
• 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 #LI-AB1 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. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected]. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility). This posting is open for thirty (30) days. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply tot his job Apply tot his job

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