Role Overview for Chief Regulatory Officer – Chicago, IL
JRG Partners is proud to announce an exclusive executive search for a transformative Chief Regulatory Officer (CRO) on behalf of our client, a pioneering leader in the medical device industry. Based in the vibrant hub of Chicago, IL, this is a career-defining opportunity for a seasoned regulatory affairs executive to shape the future of healthcare technology. Our client is renowned for its commitment to innovation, developing life-saving and life-enhancing devices that set new standards in patient care.
As the CRO, you will be the cornerstone of the company’s global expansion and product success, ensuring that groundbreaking innovations navigate the complex regulatory landscape to reach patients worldwide. This role is not merely about compliance; it is about strategic leadership, vision, and the relentless pursuit of excellence in a dynamic, fast-paced environment. You will join a forward-thinking executive team dedicated to making a tangible impact on global health.
The Chief Regulatory Officer is a pivotal senior executive position, reporting directly to the Chief Executive Officer and serving as a key member of the executive leadership team. In this capacity, you will hold ultimate responsibility for conceiving, developing, and executing the company’s global regulatory strategy. Your leadership will directly influence the entire product lifecycle, from early-stage concept and R&D to clinical trials, market approval, and post-market surveillance. You will be the organization’s primary voice and strategist in all interactions with regulatory bodies, including the FDA, Notified Bodies in Europe, and other international health authorities.
The ideal candidate is a strategic visionary with an operator’s mindset, capable of building and mentoring a world-class regulatory affairs team. You will be tasked with creating a robust regulatory framework that not only ensures compliance but also functions as a competitive advantage, enabling faster and more efficient market access for the company’s innovative product portfolio. This role demands a unique blend of deep technical expertise, business acumen, and exceptional leadership to guide the company through an exciting period of growth and technological advancement.
Key Responsibilities of Chief Regulatory Officer – Chicago, IL
The CRO’s duties are comprehensive and critical to the company’s success. Key responsibilities include:
Strategic Regulatory Leadership
Develop, articulate, and implement a forward-looking global regulatory strategy that aligns seamlessly with the company’s overarching business objectives. Provide strategic counsel to the executive team and Board of Directors on regulatory risks, opportunities, and the evolving global landscape.
Global Submissions and Approvals
Direct and oversee the preparation, submission, and maintenance of all regulatory filings. This includes, but is not limited to, Premarket Approvals (PMAs), 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), CE Markings under EU MDR, and other international registrations across key markets like APAC and LATAM.
Team Development and Management
Lead, mentor, and expand a high-performing global regulatory affairs department. Foster a culture of accountability, collaboration, continuous improvement, and professional growth. Implement scalable processes and systems to support a growing product pipeline.
Comprehensive Compliance
Serve as the ultimate authority on regulatory compliance, ensuring the organization adheres to all applicable laws, standards, and guidelines. This includes a comprehensive understanding of FDA regulations for medical devices, such as 21 CFR 820 (Quality System Regulation), ISO 13485, EU MDR, and other pertinent international standards.
Health Authority Engagement
Act as the primary point of contact and build strong, credible relationships with regulatory agencies worldwide. Lead and manage all significant communications, meetings, and negotiations with the FDA, Notified Bodies, and other health authorities.
Cross-Functional Partnership
Collaborate effectively with R&D, Clinical, Quality Assurance, Operations, and Commercial teams to provide expert regulatory input at all stages of product development. Ensure regulatory requirements are integrated into the design and development process from inception.
Regulatory Intelligence
Proactively monitor, analyze, and interpret new and evolving regulatory requirements, guidance documents, and industry trends. Disseminate this intelligence throughout the organization and translate it into actionable strategies.
Post-Market Oversight
Oversee all post-market regulatory activities, including the management of adverse event reporting, vigilance systems, product recalls, and field safety corrective actions, ensuring timely and compliant execution.
Budgetary and Financial Acumen
Develop and manage the annual budget for the regulatory affairs department, ensuring optimal allocation of resources to meet strategic goals.
Requirements for the Chief Regulatory Officer – Chicago, IL
We are seeking a distinguished leader with a proven track record of success in the medical device industry. The ideal candidate will possess the following qualifications:
Educational Background
An advanced degree (M.S., Ph.D., M.D., or J.D.) in a relevant scientific, engineering, or legal discipline is strongly preferred. A Bachelor’s degree in a related field is required.
Executive Experience
A minimum of 15 years of progressive experience in regulatory affairs within the medical device sector, with at least 7 years in a senior leadership capacity (e.g., Vice President or Senior Director) with global responsibilities.
Device Expertise
Extensive experience with a broad range of medical devices, including complex Class II and Class III devices. A strong background in software as a medical device (SaMD) and combination products is highly desirable.
Global Regulatory Mastery
Demonstrated expertise in navigating the regulatory frameworks of major global markets, particularly the US (FDA), Europe (EU MDR), Canada, and key APAC countries. Proven success in securing and maintaining product approvals in these regions.
Exceptional Leadership
Proven ability to build, lead, and inspire a global team. Must possess outstanding communication, negotiation, and influencing skills, with the ability to articulate complex regulatory concepts to diverse audiences, including board members and investors.
Strategic Mindset
Strong strategic and analytical skills, with a demonstrated ability to think critically, anticipate future trends, and develop long-term plans that drive business success.
Problem-Solving Skills
Adept at creative problem-solving and managing complex negotiations with regulatory agencies to achieve favorable outcomes.
Location and Travel
Must be based in or willing to relocate to the Chicago, IL metropolitan area. The role will require some domestic and international travel.
Benefits & Perks Offered
Our client is committed to attracting and retaining top-tier executive talent. The compensation and benefits package is designed to be highly competitive and commensurate with the strategic importance of this role. It includes:
- A highly competitive executive base salary.
- A significant annual performance-based bonus.
- A substantial long-term incentive package (e.g., stock options, RSUs) that aligns your success with the company’s growth.
- Comprehensive health, dental, vision, and life insurance plans for you and your dependents.
- A robust 401(k) retirement plan with a generous company match.
- Generous paid time off (PTO), sick leave, and paid company holidays.
- Full relocation assistance package for qualified candidates.
- A professional development budget to support continuous learning, conference attendance, and executive coaching.
- The invaluable opportunity to be a part of an executive team that is shaping the future of medical technology and improving patient lives globally.
How to Apply
This is a confidential, retained search conducted by JRG Partners. If you are a visionary regulatory leader ready to take on a new challenge and make a lasting impact, we encourage you to apply. To express your interest in this transformative leadership role, please submit your resume and a detailed cover letter outlining your qualifications and strategic vision. All applications will be treated with the strictest confidence. For more information on our expertise in this sector, please visit our Life Sciences & Medical Device Executive Search practice area page. We look forward to reviewing your application.
