Job Title

We are seeking an experienced professional with extensive knowledge of FDA regulatory frameworks and Medical, Legal, and Regulatory (MLR) review processes to join our team. In this critical role, you will serve as both a subject matter expert and a strategic advisor, providing crucial input into our product development, compliance oversight, messaging strategies, and marketing campaigns. You should be passionate about regulatory compliance, adept at collaborating cross-functionally, and enthusiastic about representing our company publicly as a primary spokesperson.Key Responsibilities:Serve as the primary expert on FDA regulatory requirements and Medical, Legal, Regulatory (MLR) review processes.Provide strategic inputs to the product development team to ensure compliance and alignment with regulatory standards.Lead and oversee internal communications and external marketing messaging, ensuring all outputs adhere to regulatory guidelines.Collaborate closely with product, compliance, legal, and marketing teams to streamline MLR review processes and ensure accuracy and compliance.Act as a spokesperson, confidently representing the company in external communications, industry forums, webinars, conferences, and media engagements.Train and mentor internal teams on MLR compliance, regulatory considerations, and best practices.Continuously monitor regulatory changes, ensuring timely implementation and communication of any updates impacting our products and marketing strategies.Qualifications:Minimum 5+ years of experience in a compliance, communications, or project management role specifically involving FDA regulatory guidelines and the MLR review process.Direct experience either working within the FDA or managing FDA-related regulatory processes in pharmaceuticals, biotech, or healthcare.Demonstrated ability to influence product development decisions based on regulatory insights.Exceptional communication skills, comfortable speaking publicly and interfacing with diverse stakeholders.Strong organizational and leadership abilities, capable of managing multiple projects simultaneously.Preferred Skills:Previous experience as an FDA official or within an FDA compliance team.Proven history as a spokesperson or public representative for compliance-related topics.Familiarity with AI-driven compliance or technology products is a plus.