VP, Global Regulatory Affairs

Danaher•Round Rock, TX

1d•$240,000 - $320,000

About The Position

Vice President, Regulatory Affairs Wondering what’s within Beckman Coulter Diagnostics? Take a closer look. At first glance, you’ll see that for more than 80 years, we’ve been committed to advancing and optimizing the laboratory to propel science and healthcare forward. Join a team where your voice is heard, you’re fully supported, and you can bring your authentic self to work. We are building a culture that celebrates the diverse backgrounds, experiences, and perspectives of all our associates. Look again, and you’ll find that we are deeply invested in your growth, offering opportunities to build a meaningful career, be innovative, and take risks—backed by the support you need to succeed. Beckman Coulter Diagnostics proudly partners with six other Diagnostics Companies under the Danaher umbrella. Together, we are moving at the speed of change to improve patient lives by delivering diagnostic tools that tackle some of the world’s most pressing healthcare challenges. The Vice President of Regulatory Affairs is a critical senior leadership role, responsible for shaping and executing regulatory strategies that ensure compliance while positioning Regulatory Affairs as a growth enabler, ensuring the business consistently earns customer trust, and driving successful product approvals globally. This role requires deep expertise in IVD regulatory frameworks across multiple regions and a proven ability to navigate complex and evolving regulatory landscapes. As the VP of Regulatory Affairs, you will provide global strategic leadership in developing and implementing regulatory strategies that align with the company’s business objectives and growth initiatives. You will collaborate with key stakeholders across functions—including Quality, New Product Development, and Commercial teams—to drive regulatory excellence and support innovation. If you thrive in a fast-paced, high-impact leadership role and are passionate about building a world-class Regulatory organization, we want to hear from you.

Requirements

Educational Background: Bachelor’s degree in a relevant scientific or technical engineering discipline with 20+ years of relevant experience, or a Master’s/Doctoral degree with 18+ years of experience. Experience must include at least 6+ years of people management, with a demonstrated ability to lead cross-functional teams.
Industry Experience: Minimum of 10-15 years of senior-level experience in regulatory affairs within the in-vitro diagnostics (IVD) industry, demonstrating expertise in highly regulated, science-driven sectors with diagnostic devices. Must have a proven track record of managing regulatory functions across multiple development and manufacturing sites.
Leadership and Strategy: Proven leadership experience in driving complex, multi-functional regulatory strategies across geographically dispersed teams and sites, fostering matrixed collaboration and moving strategy to execution through aligned capabilities.
Analytical and Problem-Solving Skills: Strong analytical, problem-solving, and decision-making abilities, applying critical thinking and effective risk assessment to anticipate regulatory challenges and develop effective mitigation strategies.
Global Regulatory Knowledge: Strong understanding of global labeling requirements (including translations), chemical compliance regulations (e.g., REACH, RoHS), and the ability to manage these complexities within a global regulatory environment, demonstrating expertise with global industry-relevant frameworks, bodies, governance, and comprehensive risk management.
AI and Technology Proficiency: Comfort and proficiency in leveraging AI and automation technologies to enhance regulatory processes, improve data-informed decision-making, and drive operational efficiencies.
Travel Requirements: Ability to travel up to 50% to various global development and manufacturing sites, as required to support global regulatory operations.

Responsibilities

Strategic Regulatory Leadership: Provide executive regulatory leadership as a core member of the Senior QRC Leadership Team, leveraging DBS methodologies to drive operational excellence, policy deployment, and performance across U.S. manufacturing sites and global quality systems, always ensuring global compliance and quality standards are met to consistently earn customer trust.
Regulatory Strategy and Agency Engagement: Set and execute global regulatory strategies across regions and business units, proactively anticipating emerging requirements and market trends; lead submissions, negotiations, and approvals with regulatory agencies, using DBS problem-solving tools to accelerate clearances and reduce regulatory risk.
Business & Pipeline Alignment: Align regulatory strategy with enterprise business goals, NPD priorities, and market expansion objectives. Partner closely with R&D, Commercial, and cross-functional teams to embed regulatory requirements early in innovation and product lifecycle planning, managing risks and ensuring business goals are met.
Leadership, Talent Development & Organizational Excellence: Build, inspire, and develop a high-performing, diverse global regulatory affairs organization, developing exceptional leaders who inspire followership and engagement. Foster a culture of accountability, collaboration, and continuous learning while strengthening niche regulatory expertise across emerging markets, novel technologies, complex NPD pathways, and lead organizational design to shape effective teams that enable strategy. Champion the development of AI-enabled regulatory capabilities to ensure the team stays ahead of evolving global requirements and drives innovative regulatory strategy.
Compliance Governance & Global Standards: Ensure enterprise compliance with global regulatory requirements, including labeling, translations, REACH, RoHS, and chemical regulations. Oversee global labeling governance and ensure consistent, accurate, compliant regulatory practices across markets.
Financial & Operational Stewardship: Manage the Regulatory Affairs budget with strong financial discipline, applying DBS financial tools to optimize resource allocation, streamline regulatory processes, and ensure high-quality outcomes within financial parameters.
Continuous Improvement, Innovation & Risk Management: Champion continuous improvement through DBS methodologies, Kaizen, AI, and automation. Provide scientific/regulatory expertise to NPD teams and proactively mitigate regulatory risks using structured DBS risk-management tools to protect timelines and approvals.