Director/ Associate Director, International Regulatory Affairs #4809

The Director/Associate Director, International 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, influencing external regulatory policy, and ensuring global compliance in alignment with corporate objectives. The Director partners closely with executive leadership to guide portfolio and business-critical decisions, prepare materials and presentations required for high-level interactions with health authorities, and develop the next generation of regulatory leaders.

Responsibilities:

• Define and oversee global regulatory strategies for the company's product portfolio, ensuring alignment with business priorities and global requirements.
• Drive Galleri commercialization across key international markets, specifically the EU, Asia/Pacific, the Middle East (including Israel and Saudi Arabia), and the UK.
• Working closely with senior executives, provide strategy and oversight for all regulatory submissions, product approvals, and lifecycle management activities across geographies.
• Partner with cross-functional teams, and executive leadership (R&D, Quality, Clinical, Commercial, Manufacturing) to integrate regulatory considerations into enterprise strategy and portfolio governance.
• Anticipate global regulatory and policy shifts, assess impact, and shape proactive company responses.
• Ensure organizational readiness for regulatory inspections, audits, and interactions with authorities at the highest level.
• Influence international regulatory policy through participation in industry forums, standards bodies, and regulatory working groups.
• Champion innovation and transformation initiatives within the regulatory function, including digital enablement, automation, and process modernization.

Required Qualifications:

• Advanced degree in molecular biology, genomics, or diagnostics; PhD preferred.
• 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)

Preferred Qualifications:

• Global regulatory experience with mastery of US, EU, and international frameworks, submission pathways, and compliance requirements
• Exceptional communication and influencing skills, with credibility at the executive and global health authority levels.
• Strong portfolio and enterprise decision-making capability, balancing regulatory risk, innovation, and business priorities.
• Advanced proficiency in enterprise regulatory systems, global submission platforms, and compliance tools.
• Lead the development, preparation, review, and execution of international regulatory submissions and product registrations.
• Establish filing strategies, submission plans, timelines, dependencies, and governance necessary to support international commercialization.
• Ensure appropriate maintenance of regional registrations and compliance with applicable regulatory databases and registration systems, including:
• EU EUDAMED requirements for device registration and UDI;
• Saudi Arabian regulatory registration systems, including GHAD, and
• UAE MOHAP regulatory and e-services requirements.
• Establish processes and controls to maintain accurate and current international regulatory records, registrations, commitments, and submissions.
• Monitor international regulatory commitments and ensure timely execution of required post-approval or post-registration activities.

Physical Demands and Work Environment:

• Leadership role with a broad, global scope and strategic impact, and opportunity to grow.
• Requires flexibility to operate across multiple time zones and respond to urgent global regulatory needs.
• Domestic and international travel required for regulatory negotiations, industry representation, and leadership responsibilities.
• As the organization evolves, the employee must be adaptable to taking on additional responsibilities, new technologies, or cross-functional projects to meet changing business needs.

This role could be based either in Sunnyvale, DC or RTP. Our current flexible work arrangement policy in the UK 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.