Description
The Regulatory Affairs Subject Matter Expert (SME) provides senior-level regulatory leadership, technical expertise, and strategic guidance in support of medical product development and acquisition programs.
The SME serves as the organization's principal advisor on regulatory requirements, policies, and pathways governing the development, testing, approval, and lifecycle management of drugs, biologics, blood and blood products, medical devices, diagnostics, and other regulated medical solutions.
Key responsibilities include:
- Developing regulatory strategies and advising on regulatory risks and opportunities
- Coordinating regulatory agency interactions and reviewing scientific and clinical documentation
- Ensuring compliance with applicable FDA, Department of War (DoW), Defense Health Agency (DHA), and international regulatory requirements
- Preparing and supporting regulatory submissions and documentation
- Collaborating with multidisciplinary teams to ensure regulatory compliance throughout the product lifecycle
- Providing training, mentoring, and technical guidance on regulatory requirements and best practices
Requirements:
- Bachelor's degree in Regulatory Affairs, Biology, Chemistry, Biomedical Sciences, Pharmacy, Public Health, Engineering, or a related scientific discipline
- Minimum 10 years of progressively responsible experience supporting regulatory affairs activities for pharmaceutical, biologic, medical device, blood product, combination product, or other regulated healthcare product development programs
- Current and active Regulatory Affairs Certification (RAC)
- Extensive knowledge of FDA regulatory requirements and strong understanding of medical product development lifecycle activities
Benefits:
- Full-flex work week
- 401K with company match
- Comprehensive health and wellness packages
- Internal mobility team
- Professional growth opportunities
- Paid education and certifications
- Paid vacation and holidays