Vice President, Global Head of Regulatory Affairs

Overview

In this role, you shape and execute the Global Regulatory Affairs strategy for the IVD and life sciences portfolio, guiding regulatory pathways and milestones across the product lifecycle. You will lead regulatory submissions with FDA, EU, and other authorities, and steer postmarket surveillance to ensure ongoing compliance. You’ll partner with leaders to influence decisions, set policies, and harmonize cross-functional plans. This position offers the chance to drive market access and strengthen QIAGEN’s regulatory excellence within a global team.

Pay / Benefits

• Bonus/Commission
• Local benefits
• Referral Program
• Volunteer Day
• Internal Academy (QIALearn)
• Employee Assistance Program (EAP)

Responsibilities

• Develop and execute the global regulatory strategy for IVD and life sciences products
• Lead major submission processes with FDA, EU and other authorities across the full product lifecycle
• Oversee postmarket surveillance activities for IVD products
• Influence business decisions by assessing regulatory impact and advising on standards and guidance
• Create and maintain policies, procedures, and best practices to ensure regulatory compliance
• Ensure cross-functional alignment of regulatory requirements with product development, risk assessments, and validation plans
• Provide strategic regulatory guidance and keep teams informed of policy changes
• Build and develop the Global Regulatory Affairs team and manage the operating budget
• Improve regulatory processes for consistency and efficiency across teams
• Foster collaboration with regulatory agencies and external organizations to support market access

Key requirements

• 10+ years of regulatory/government affairs leadership in IVD
• Experience leading large global teams across geographies
• Proven record in pre-clinical/clinical strategies for clinical IVD products
• Track record in postmarket surveillance and FDA submissions (registrations, MDRs, Vigilance)
• Knowledge of global regulatory frameworks, FDA QMSR, ISO 13485
• Strong cross-functional project management and leadership with regulatory agencies

• excellent written and verbal communication
• inspiring and ethical leadership
• cross-functional collaboration
• regulatory strategy development
• FDA submissions and registrations
• IVD regulatory knowledge

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