Q

QIAGEN

Molecular testing consumables, instruments, software

Vice President, Global Head of Regulatory Affairs

Full-Time
$250k - $300k+ Bonus plan + Stock options
Expert
Germantown, MD, USA+2 moreMore locations: Hilden, Germany | Manchester, UK
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • At least 10 years of experience in regulatory and/or government affairs leadership for in vitro diagnostic companies, including successful pre-market submissions.
  • Prior experience in a senior leadership role managing large, global teams across multiple geographies.
  • Strategic experience developing and implementing pre-clinical and clinical strategies for clinical in vitro diagnostic products, implementing regulatory systems, and assuring compliance with applicable regulations.
  • A proven track record in problem solving and developing risk-based solutions.
  • Prior responsibility for postmarket surveillance activities and FDA submissions, including registrations, complaint review for reportability, and generating and submitting agency reports such as annual reports, Medical Device Reports, and Vigilance reports.
  • Understanding of global regulatory affairs, government affairs, FDA Quality Management System Regulation, and ISO 13485.
  • Well-developed cross-functional project and team management skills.
  • Experience interfacing and working with regulatory agencies, including the FDA.
  • Ability to communicate complex regulatory requirements in a straightforward and practical manner, verbally and in writing.
  • Ability to work cross-functionally and independently, take a stand, and ensure completion of time-critical projects.
  • Strategic thinking and ability to find novel solutions to complex business challenges.
  • Strong ethics and commitment to integrity.
Responsibilities
  • Develop and execute the Global Regulatory Affairs strategy for the in vitro diagnostics and life sciences portfolios, including regulatory pathways, milestones, and deliverables, ensuring regulatory work supports company strategy, governance, and ongoing compliance.
  • Provide expert leadership on FDA, European Union, and other major submission processes and requirements across the product lifecycle, including oversight of postmarket surveillance for in vitro diagnostic products.
  • Partner with business leaders to assess the impact of new or changing regulations, standards, and guidance, influence decisions, and support adoption.
  • Lead regulatory assessments of product risk and safety issues and ensure consistent execution of regulatory processes across the organization.
  • Create solutions to complex regulatory challenges by setting policies and procedures, aligning cross-functional teams, and maintaining working relationships with government and non-government organizations that affect market access and distribution.
  • Develop and maintain policies, procedures, and best practices to ensure compliance with applicable laws, regulations, and standards for products manufactured and developed at QIAGEN.
  • Provide strategic regulatory guidance and run internal processes to keep teams informed about relevant policies, standards, and regulatory changes.
  • Collaborate with cross-functional teams to integrate regulatory requirements into product development plans, risk assessments, validation studies, and submission strategies.
  • Report 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 reinforce QIAGEN’s broader culture through mentoring and leadership.

About the company

Q

QIAGEN

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Website

QIAGEN provides molecular testing solutions for DNA, RNA, and proteins used by researchers and clinicians in life sciences and diagnostics. It offers an end-to-end portfolio spanning sample technologies, assay technologies, and bioinformatics software to guide workflows from sample to data interpretation. Notable products include QIAseq UPXome RNA Library Kits, the QIAstat Dx Viral Vesicular Panel, and the QIAstat Dx Analyzer, a scalable digital PCR system. Its goal is to help users obtain fast, reliable molecular insights by offering an integrated mix of hardware, reagents, and software that support research and patient care.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Venlo, Netherlands

Founded

1984

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Simplify's Take

What believers are saying

  • On September 28, 2026, FDA cleared QIAstat-Dx bloodstream infection panels covering 33 targets.
  • On September 24, 2026, QIAGEN launched QIAmini, its third sample-prep system of 2026.
  • Q2 2026 sales held at $535 million, and adjusted EPS beat guidance at $0.62.

What critics are saying

  • U.S. immigration testing demand dragged QuantiFERON growth to 1% in Q2 2026.
  • Instrument sales fell in Q2 2026, signaling weak lab capital spending across markets.
  • The strategic review and private-equity sale talks stall, trapping QIAGEN in slow-growth limbo.

What makes QIAGEN unique

  • QIAGEN's 5,200-plus QIAstat-Dx placements lock labs into recurring consumables revenue.
  • Its integrated sample-to-result platforms bundle extraction, PCR, and analytics in one workflow.
  • QIAGEN spans research and diagnostics, with FDA-cleared menus across respiratory, GI, and bloodstream infections.

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Benefits

  • Bonus/Commission
  • Local benefits
  • Referral Program
  • Volunteer Day
  • Hybrid Work Options
  • Employee Assistance Program

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
EuropaWire
Oct 14th, 2026
QIAGEN brings Global Tuberculosis specialists together as funding pressures test TB progress.

QIAGEN brings Global Tuberculosis specialists together as funding pressures test TB progress. The Global TB Clinical and Educational Summit runs from 13 to 16 October, combining online sessions with an on-site meeting in London as experts address prevention, screening, care and the impact of funding cuts. QIAGEN supports tuberculosis control through education and diagnostic testing, including blood-based testing used to detect TB infection. QIAGEN N.V. is convening tuberculosis specialists from around the world for its Global TB Clinical and Educational Summit from 13 to 16 October 2026, as persistent disease burden and growing pressure on global health funding challenge progress against TB. The company said the Summit will focus on prevention, screening and care, while also highlighting the role of education and diagnostic testing, including its QuantiFERON-TB Gold Plus blood-based assay. The programme includes online sessions from 13 to 15 October and online and on-site participation at the Royal College of Physicians in London on 16 October. (PRESS RELEASE) VENLO, Netherlands, 14-Oct-2026 - /EuropaWire/ - QIAGEN N.V. will bring together tuberculosis experts from around the world for the Global TB Clinical and Educational Summit from 13 to 16 October 2026, as a persistent disease burden and growing pressures on global health funding put renewed focus on tuberculosis prevention, screening and care. According to the World Health Organization's Global Tuberculosis Report 2025, an estimated 10.7 million people worldwide developed tuberculosis in 2024 and nearly 1.2 million died from the disease. While global TB deaths have declined, the number of people developing the disease remains persistently high, highlighting the need to sustain prevention, detection and treatment efforts. The Summit comes as cuts to international health funding place TB programmes under increasing strain. QIAGEN said the World Health Organization has warned that reductions in donor funding threaten essential TB prevention as well as diagnostic and treatment services. A key discussion on 15 October, "TB at risk - the global consequences of funding cuts and the future of tuberculosis control," will bring together experts from academia, clinical practice, advocacy and international TB organisations. "The world has made progress against tuberculosis, but that progress cannot be taken for granted," said Dr. Christine Ginocchio, Chief Medical Officer at QIAGEN. "Millions of people still develop TB every year, and pressure on funding and public health systems could slow further advances. Bringing experts together, strengthening education and identifying people with TB infection are practical ways we can help sustain momentum toward better prevention and care." QIAGEN supports TB control through both education and diagnostic testing. Its activities include the annual Global TB Clinical and Educational Summit and QuantiFERON-TB Gold Plus (QFT-Plus), a blood-based interferon-gamma release assay used to detect TB infection and TB disease. QFT-Plus can be used to detect TB infection as an aid to identify people who may benefit from preventive treatment, particularly those at increased risk for TB disease. More than 160 million QuantiFERON-TB tests have been sold worldwide since launch, with customers in more than 130 countries and more than 2,700 peer-reviewed publications involving QuantiFERON. For more than a decade, the Global TB Clinical and Educational Summit has brought together clinicians, laboratory professionals, researchers, nurses, advocates, survivors and public health leaders to exchange knowledge and experience in TB detection, treatment, prevention and patient care. The 2026 Global TB Summit, under the theme "One world, one fight: Let's end TB together," will take place online from 13 to 15 October and online and on-site at the Royal College of Physicians in London on 16 October. Discussions will focus on major challenges facing TB control, including prevention and screening, drug-resistant and childhood TB, vulnerable populations and access to care. Sessions will also examine the role of interferon-gamma release assays in screening people at increased risk of developing TB disease, including patients receiving kidney dialysis or biologic therapy, immunocompromised patients and older adults. The Summit is free to attend and offers CME- and CPD-accredited learning. Further information on the programme and registration is available at QIAGEN's TB Summit page. About QIAGEN. QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of June 30, 2026, QIAGEN employed about 5,500 people across more than 35 locations. For more information, visit http://www.qiagen.com. Forward-Looking statement. Certain statements in this press release may constitute forward-looking statements within the meaning of the U.S. federal securities laws. These statements include, among others, statements regarding QIAGEN's products, product development and launches, regulatory approvals, market opportunities and future business performance. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially. These risks include, among others, the development and commercial success of new products, regulatory approvals, competition, changes in customer demand and funding, economic and market conditions, supply chain disruptions, cybersecurity incidents, litigation and other risks described under "Risk Factors" in QIAGEN's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. QIAGEN undertakes no obligation to update any forward-looking statement except as required by law. Investor Relations contacts. Daniel Wendorff Vice President, Head of Investor Relations Mobile: +49 152 01811322 [email protected] Dr. Domenica Martorana Associate Director Global Investor Relations Mobile: +49 152 018 11244 [email protected] Alexandra Koenig Investor Relations Coordinator Mobile: +49 152 018 11709 [email protected] Press contacts. John Gilardi Vice President, Head of Corporate Communications, Global Germany: +49 2103 29 11711 Mobile: +49 152 018 11711 [email protected] Lisa Specht Manager Public Relations, Corporate Communications Germany: +49-2103-29-14181 Mobile: +49-152-018-11381 [email protected] Jana Radoi Corporate Communications Coordinator, Global Mobile: +49 152 018 11670 [email protected] Heeyoung Lee Asia-Pacific region topics South Korea: +82 226265788 Mobile: +82 01093389650 [email protected] Natalia Silo Latin America region topics Mobile: +55 11 98702 0137 [email protected]

BioPharma Watch
Oct 13th, 2026
QIAGEN convenes global tuberculosis experts as new pressures challenge progress against tuberculosis.

QIAGEN convenes global tuberculosis experts as new pressures challenge progress against tuberculosis. Key Takeaway: QIAGEN N.V. is hosting the Global TB Clinical and Educational Summit from October 13-16, gathering tuberculosis experts to address the ongoing challenges posed by the disease. With an estimated 10.7 million new cases and nearly 1.2 million deaths in 2024, the summit aims to enhance focus on prevention, screening, and care amidst increasing pressures on global health funding. Market sentiment analysis. Positive factors. * Global experts are convening to address tuberculosis challenges. * Focus on prevention, screening, and care is being renewed. * The summit aims to tackle the persistent disease burden. VENLO, Netherlands & GERMANTOWN, Md.-(BUSINESS WIRE)- $QGEN #QIAGEN-QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) will bring together tuberculosis experts from around the world for the Global TB Clinical and Educational Summit from October 13-16 as a persistent disease burden and growing pressures on global health funding put renewed focus on tuberculosis prevention, screening and care. An estimated 10.7 million people worldwide developed tuberculosis in 2024 and nearly 1.2 million died from the d Frequently asked questions. When is the Global TB Summit hosted by QIAGEN? The Global TB Clinical and Educational Summit is from October 13-16. What is the focus of the QIAGEN TB Summit? The summit focuses on tuberculosis prevention, screening, and care. How many people developed tuberculosis in 2024? An estimated 10.7 million people developed tuberculosis in 2024. What are the current pressures on tuberculosis progress? Growing pressures on global health funding challenge progress against tuberculosis.

EuropaWire
Oct 7th, 2026
QIAGEN adds evidence-traceable AI tools to bioinformatics and drug discovery workflows.

QIAGEN adds evidence-traceable AI tools to bioinformatics and drug discovery workflows. IPA Investigator introduces natural-language biological analysis while the QIAGEN Discovery Platform extends AI into automated drug discovery workflows. QIAGEN has introduced new AI capabilities for biological and genomic data analysis and drug discovery workflows. QIAGEN has introduced new artificial intelligence capabilities across QIAGEN Digital Insights to help researchers analyze biological and genomic data while keeping the scientific evidence behind results visible. The launch includes IPA Investigator for QIAGEN Ingenuity Pathway Analysis and the new QIAGEN Discovery Platform for drug discovery workflows. QIAGEN says the additions build on more than 25 years of biomedical knowledge and bioinformatics tools used by around 150,000 users. (PRESS RELEASE) VENLO, Netherlands, 7-Oct-2026 - /EuropaWire/ - QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) has announced new artificial intelligence (AI) capabilities designed to help researchers analyze complex biological and genomic data faster while keeping the scientific evidence behind the results visible. The expansion includes IPA Investigator, a new AI research companion for QIAGEN Ingenuity Pathway Analysis (IPA), and the new QIAGEN Discovery Platform, which extends these capabilities into automated drug discovery workflows. The new offerings build on more than 25 years of biomedical knowledge from QIAGEN Digital Insights (QDI), whose bioinformatics solutions are used by around 150,000 users. The global market for AI in bioinformatics is projected to more than double from about $12 billion in 2026 to more than $25 billion by 2031, according to Mordor Intelligence. As researchers increasingly use AI to analyze growing volumes of biological and genomic data, QIAGEN said speed alone is not enough. The company combines AI with expert-reviewed biological, genomic and clinical information so scientists can examine the evidence behind the results. "AI can deliver an answer in seconds, but in science, speed without evidence can create false confidence," said Dominic John, Vice President and Head of QIAGEN Digital Insights. "Our approach is to combine the speed of AI with expert-curated biomedical knowledge and traceable scientific evidence so researchers can examine the evidence behind the results and evaluate them for themselves." IPA Investigator allows scientists to ask questions about their data in natural language. It can identify relevant biological relationships, recommend analyses and carry them out within IPA. Researchers can then connect their own experimental data with existing biological knowledge to better understand disease, identify potential drug targets and decide what to investigate next. At the University of Bergen in Norway, researchers tested IPA Investigator using complex datasets that deliberately introduced misleading sample comparisons. "We deliberately introduced misleading comparisons to see how IPA Investigator would respond. It identified the problem, cautioned us against overinterpreting the results and suggested a better experimental design," said Dr. Simona Chera, Professor at the University of Bergen. QIAGEN is also introducing the QIAGEN Discovery Platform, which enables the integration of AI with QIAGEN's biomedical knowledge base and molecular data to support drug discovery. The platform is designed to help researchers identify potential drug targets and biomarkers, generate research hypotheses and automate parts of the discovery process. The launches are part of a broader rollout of AI across QIAGEN Digital Insights, including AI-powered translation in QIAGEN Clinical Insight (QCI) Interpret and machine learning combined with expert-reviewed information in Franklin by QIAGEN. About QIAGEN. QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of June 30, 2026, QIAGEN employed about 5,500 people across more than 35 locations. For more information, visit http://www.qiagen.com. Forward-Looking statement. Certain statements in this press release may constitute forward-looking statements within the meaning of the U.S. federal securities laws. These statements include, among others, statements regarding QIAGEN's products, product development and launches, regulatory approvals, market opportunities and future business performance. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially. These risks include, among others, the development and commercial success of new products, regulatory approvals, competition, changes in customer demand and funding, economic and market conditions, supply chain disruptions, cybersecurity incidents, litigation and other risks described under "Risk Factors" in QIAGEN's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. QIAGEN undertakes no obligation to update any forward-looking statement except as required by law. IR contacts. Daniel Wendorff Vice President Head of Investor Relations Mobile: +49 152 01811322 [email protected] Dr. Domenica Martorana Associate Director Global Investor Relations Mobile: +49 152 018 11244 [email protected] Alexandra Koenig Investor Relations Coordinator Mobile: +49 152 018 11709 [email protected] Press contacts. John Gilardi Vice President Head of Corporate Communications Global Germany: +49 2103 29 11711 Mobile: +49 152 018 11711 [email protected] Lisa Specht Manager Public Relations Corporate Communications Germany: +49-2103-29-14181 Mobile: +49-152-018-11381 [email protected] Jana Radoi Corporate Communications Coordinator Global Mobile: +49 152 018 11670 [email protected] Heeyoung Lee Asia-Pacific region topics South Korea: +82 226265788 Mobile: +82 01093389650 [email protected] Natalia Silo Latin America region topics Mobile: +55 11 98702 0137 [email protected]

Yahoo Finance
Oct 6th, 2026
QIAGEN launches AI bioinformatics tools as market set to double to $25B by 2031

QIAGEN has launched new AI-powered bioinformatics tools to help researchers analyse biological and genomic data while maintaining visibility of scientific evidence. The expansion includes IPA Investigator, an AI research companion that allows scientists to ask questions in natural language, and the QIAGEN Discovery Platform for drug discovery workflows. The tools build on over 25 years of biomedical knowledge from QIAGEN Digital Insights, used by around 150,000 researchers. The global AI bioinformatics market is projected to grow from $12 billion in 2026 to over $25 billion by 2031, according to Mordor Intelligence. IPA Investigator can identify biological relationships, recommend analyses, and help researchers understand disease and identify potential drug targets. The QIAGEN Discovery Platform enables integration of AI with molecular data to support drug discovery, helping identify drug targets and biomarkers whilst automating parts of the discovery process.

MarketScreener
Oct 6th, 2026
QIAGEN N.V. Expands ai-powered bioinformatics with IPA Investigator and QIAGEN Discovery Platform.

QIAGEN N.V. Expands ai-powered bioinformatics with IPA Investigator and QIAGEN Discovery Platform. Published on 10/06/2026 at 04:05 pm EDT S&P Capital IQ QIAGEN N.V. announced new artificial intelligence (AI) capabilities to help researchers analyze complex biological and genomic data faster while keeping the scientific evidence behind the results visible. The expansion includes IPA Investigator, a new AI research companion for QIAGEN Ingenuity Pathway Analysis (IPA), and the new QIAGEN Discovery Platform, which extends these capabilities into automated drug discovery workflows. As researchers increasingly use AI to analyze growing volumes of biological and genomic data, speed alone is not enough. QIAGEN combines AI with expert-reviewed biological, genomic and clinical information so scientists can examine the evidence behind the results. IPA Investigator allows scientists to ask questions about their data in natural language. It can identify relevant biological relationships, recommend analyses and carry them out within IPA. Researchers can then connect their own experimental data with existing biological knowledge to better understand disease, identify potential drug targets and decide what to investigate next. At the University of Bergen in Norway, researchers tested IPA Investigator using complex datasets that deliberately introduced misleading sample comparisons. QIAGEN is also introducing the QIAGEN Discovery Platform, which enables the integration of AI with QIAGEN?s biomedical knowledge base and molecular data to support drug discovery. The platform is designed to help researchers identify potential drug targets and biomarkers, generate research hypotheses and automate parts of the discovery process. The launches are part of a broader rollout of AI across QIAGEN Digital Insights, including AI-powered translation in QIAGEN Clinical Insight (QCI) Interpret and machine learning combined with expert-reviewed information in Franklin by QIAGEN. (C) S&P Capital IQ - 2026