Vice President, Global Head of Regulatory Affairs

Overview   At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible.  We’re dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We’re always striving to identify talented individuals to join our exceptional teams.  

We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let's shape the future of biological discovery.

‎ About the opportunity This is a senior global leadership role in Regulatory Affairs responsible for defining and executing the worldwide regulatory strategy for QIAGEN's IVD (In Vitro Diagnostics) and Life Sciences portfolio. The position oversees all regulatory activities across the product lifecycle, including pre-market submissions, post-market surveillance, compliance, regulatory intelligence, and global team leadership.

The successful candidate will serve as the company's senior regulatory expert, partnering with executive leadership, regulatory agencies (FDA and global authorities), and cross-functional teams to ensure products achieve and maintain regulatory approval while supporting business growth and market access.

Your tasks include

Develop and execute the Global Regulatory Affairs strategy for the IVD and life sciences portfolios, including clear regulatory pathways, milestones, and deliverables. Ensure regulatory work supports company strategy, governance, and ongoing compliance with the company’s mission and standards.

Provide expert leadership on FDA, EU, and other major submission processes and requirements across the full product lifecycle, including oversight of postmarket surveillance activities for IVD products. Partner with business leaders to assess impact, influence decisions, and support adoption of new or changing regulations, standards, and guidance.

Lead the regulatory assessment of product risk and safety issues and ensure consistent execution of regulatory processes across the organization. Create practical solutions to complex regulatory challenges by setting policies and procedures, aligning cross-functional teams, and maintaining strong working relationships with government and non-government organizations that affect market access and distribution.

Ensure compliance with applicable laws, regulations, and standards by developing and maintaining policies, procedures, and best practices for products manufactured and developed vide strategic regulatory guidance and run internal processes that keep teams informed about relevant policies, standards, and regulatory changes. Ensure strong collaboration between Regulatory Affairs and cross-functional teams so regulatory requirements are built into product development plans, risk assessments, validation studies, and submission strategies.

Deliver clear reporting on regulatory activities, risks, mitigations, and likelihood of success.

Build and develop the Global Regulatory Affairs team through talent development, competency building, and resource planning. Set and execute departmental goals to meet business objectives.

Manage the annual Global Regulatory Affairs operating budget. Continuously improve the Global Regulatory Affairs function to ensure consistent and efficient processes and guidance across teams. Foster a strong department culture and help reinforce QIAGEN’s broader culture through mentoring and leadership.

Your profile The ideal candidate will have (10+) years of experience in regulatory and/or government affairs leadership for in vitro diagnostic (IVD) companies, including successful pre-market submissions.

Prior experience in a senior leadership role managing large, global teams across multiple geographies.

Strategic experience and ability,…