Jobs in Washington, DC

About the role

The Associate Director, Global Regulatory Affairs supports the vision, and strategic direction for the company's global regulatory function. This role reports to the Vice President, Head of Regulatory and is accountable for driving regulatory strategy across all portfolios—with a focus on diagnostics and device commercialization—influencing external regulatory policy, and ensuring global compliance in alignment with corporate objectives. The Associate Director/Director partners closely with executive leadership to guide portfolio and business-critical decisions, supports the company by preparing materials and presentations required for high-level interactions with health authorities, and develops the next generation of regulatory leaders. This is a hybrid role based in Washington, D.C. Our current flexible work arrangement policy requires that a minimum of 40%, or 16 hours, of your total work week be on-site. Your specific schedule, determined in collaboration with your manager, will align with the team and business needs and could exceed the 40% requirement for the site.

What you'll bring

• Advanced degree in molecular biology, genomics, or diagnostics
• 15+ years of relevant regulatory affairs or related industry experience
• Master's degree with 12+ years, or PhD with 10+ years
• Proven record of success leading enterprise-level regulatory strategies and high-impact submissions, particularly with experience in international diagnostics/device commercialization.
• Extensive experience interacting at senior levels with global regulatory agencies and influencing international policy
• Demonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity, including
• Regulatory submission of medical devices (e.g., IVDD, IVDR, FDA 21 CFR, UK MDR 2002)
• GMP quality management systems (e.g., ISO 13485) and Risk assessment frameworks (e.g., ISO 14971)
• Clinical laboratory regulations (e.g., CAP, CLIA, NYSDOH, ISO 15189)
• Protected health information (e.g., HIPAA, GDPR)
• Development and Operations within a regulated clinical study environment (e.g., ICH E6 (GCP), ISO 20916, FDA 21 CFR Part 11, Part 50, Part 54, Part 56)
• Global regulatory expert with mastery of U.S., EU, and international frameworks, submission pathways, and compliance requirements

Benefits