Job Description

A leading global healthcare innovator is seeking a Director of Regulatory Strategy to join its Illinois-based team. This strategic leadership role is ideal for a seasoned regulatory affairs professional passionate about shaping policy and driving initiatives that improve patient outcomes worldwide.

The Director will be Responsible for…

• Develop and implement forward-looking regulatory strategies across domestic and international markets.
• Lead cross-functional project execution using established methodologies.
• Oversee budgets, timelines, and regulatory processes for major product portfolios.
• Provide expert guidance to support business planning and compliance across diverse industries.
• Facilitate strategic planning sessions with internal stakeholders and external partners.
• Ensure pre-approval and post-approval complaince activities are completed correctly.
• Writing and reviewing FDA submissions for Medical Device and IVD products.

The Director will have the Following Qualifications:

• PhD. in a scientific field (e.g., Biology, Chemistry, Microbiology, Pharmacy) strongly preferred, Master's or Bachelor's degree acceptable with extensive experience.
• 10+ years of experience in regulatory affairs within highly regulated sectors.
• Proven success in developing regulatory strategies and managing complex programs.
• Demonstrated experience with IVD (In Vitro Diagnostic) submissions, 510(k) submissions, and new product development.
• Strong track record of collaboration with regulatory bodies such as the FDA. Previous work at the FDA is preferred.

This is a unique opportunity to influence global health initiatives and contribute to a mission-driven organization committed to innovation and excellence in patient care.

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