VP of Regulatory of Affairs

VP of Regulatory Affairs Job Description Position Summary The Vice President of Regulatory Affairs is a senior executive responsible for developing, implementing, and leading the organizations regulatory strategy across all products, services, and clinical operations. This role ensures full compliance with FDA, HIPAA, CLIA, FTC, and all applicable federal/state regulations while partnering closely with R&D, Clinical, QA, Legal, and Executive Leadership. The VP of Regulatory drives regulatory submissions, oversees risk mitigation, ensures scientific and clinical claims are compliant, and supports company expansion into new markets, technologies, and product categories. Key Responsibilities Regulatory Strategy & Leadership Develop and execute the companys regulatory strategy for new and existing products. Serve as the primary regulatory advisor to the CEO and executive team. Oversee regulatory planning for product launches, clinical trials, labeling, marketing claims, diagnostics, and wellness products. Ensure alignment between Regulatory, QA, Clinical, R&D, Marketing, and Operations. Regulatory Compliance Ensure compliance with: FDA (DSHEA, 510(k), PMA), HIPAA, CLIA, FTC, and state-specific regulations. Oversee regulatory audits, inspections, and interactions with federal/state agencies. Maintain up-to-date knowledge on evolving laws and communicate changes to leadership. Develop and maintain SOPs, regulatory documentation, and quality frameworks. Regulatory Submissions & Documentation Lead and approve all regulatory submissions, including 510(k), IND, PMA, GRAS, clinical protocols, and labeling packages. Oversee the creation, review, and approval of technical files, risk assessments, and validation reports. Ensure accuracy of all product claims, marketing language, and scientific communications. Cross-Functional Leadership Work closely with R&D and Clinical teams to ensure regulatory considerations are integrated early in development. Partner with Quality Assurance to ensure audit readiness, corrective actions, and continuous improvement. Support Commercial, Sales, and Marketing with compliant messaging and training. Represent the company to regulatory bodies, external partners, and medical experts. People Leadership Build, lead, and mentor a high-performing regulatory team. Set team KPIs aligned with business priorities. Provide regulatory training across departments. Qualifications Masters degree in a scientific field required; PhD or PharmD preferred. 10+ years of progressive regulatory experience in biotech, diagnostics, supplements, life sciences, or medical devices. Deep knowledge of FDA, CLIA, HIPAA, GMP, GLP, and quality management systems. Proven experience leading regulatory submissions and regulatory strategy. Strong leadership, communication, and cross-functional collaboration skills. Ability to thrive in an innovative, fast-moving, science-driven environment.