Vice President, Global Head of Regulatory Affairs

QIAGEN•Germantown, TN

4d•Hybrid

About The Position

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 at QIAGEN. Provide 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.

Requirements

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, having demonstrated success related to the development and implementation of pre-clinical and clinical strategies for clinical IVD products, implementation of regulatory systems, and assuring compliance to all applicable regulations.
Proven track record of success 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/submitting agency reports (i.e., annual reports, MDRs, Vigilance, etc.).
Understanding of global regulatory, government affairs, FDA QMSR, and ISO 13485 required.
Well-developed cross-functional project and team management skills.
Strong leadership and demonstrated experience in interfacing with and working with regulatory agencies, including FDA.
Excellent verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner.
Passionate leader who inspires others to deliver results.
Creates an environment where team members feel capable, challenged, and supported, with a strong sense of ethics and a commitment to integrity.
Ability to work well cross-functionally, and in team settings and independently, take a stand and ensure completion of time-critical projects.
Strategic thinker, with ability to find novel solutions to complex business challenges is an absolute necessity.
Visionary thinking with a desire to excel, inspiring others.
Structured and well organized.
Confident and engaging personality with excellent influencing skills.
Good business acumen, pragmatic, and business oriented.
Able to identify and focus on the key priorities.
Self-starting, self-reliant, courage of conviction.

Responsibilities

Develop and execute the Global Regulatory Affairs strategy for the IVD and life sciences portfolios.
Ensure regulatory work supports company strategy, governance, and ongoing compliance.
Provide expert leadership on FDA, EU, and other major submission processes and requirements.
Oversee postmarket surveillance activities for IVD products.
Partner with business leaders to assess impact, influence decisions, and support adoption of new or changing regulations.
Lead the regulatory assessment of product risk and safety issues.
Ensure consistent execution of regulatory processes across the organization.
Create practical solutions to complex regulatory challenges by setting policies and procedures.
Align cross-functional teams and maintain strong working relationships with government and non-government organizations.
Ensure compliance with applicable laws, regulations, and standards.
Develop and maintain policies, procedures, and best practices for products.
Provide strategic regulatory guidance and run internal processes.
Ensure strong collaboration between Regulatory Affairs and cross-functional teams.
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.
Foster a strong department culture and help reinforce QIAGEN’s broader culture through mentoring and leadership.