Senior Regulatory Affairs Manager

Responsibilities

• Lead and develop a high‑performing team focused on product release and regulatory execution
• Lead end‑to‑end regulatory product release strategy and execution, ensuring compliance with global regulatory requirements
• Drive process standardization, simplification, and automation across product release workflows
• Lead data quality initiatives to support compliant global submissions and product distribution
• Oversee regulatory distribution control processes (e.g., GTS/SAP) to enable timely and accurate product release
• Lead continuous improvement initiatives focused on cycle time, quality, and scalability of release processes
• Establish and monitor KPIs, dashboards, and reporting to track performance and compliance
• Build organizational capability in regulatory systems, data, and operational execution

• Bachelor’s degree
• 7+ years of experience supporting or leading product release, distribution control, or regulatory operations processes (or 5+ years with advanced degree)
• 5+ years of managerial experience
• Strong knowledge of global regulatory requirements impacting product distribution (FDA, EU MDR, international markets)
• Organizational skills and highly detail oriented
• Intermediate knowledge of spreadsheet and database applications (Microsoft Office, and SharePoint)
• Analytical and problem‑solving skills
• Effective project management skills
• Experience with GTS/SAP, UDI (GUDID/EUDAMED), and/or RIM systems
• Experience in regulatory data management, governance, or digital transformation
• Experience driving process harmonization across global organizations
• Proven ability to work in complex, matrixed organizations and influence stakeholders
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.