Global Regulatory Strategy Director - MedTech Devices

The Mullings Group; Chicago (IL); On-site; USD 180,000 - 240,000; Full time

Job summary

Organ Recovery Systems in Itasca, IL seeks a Director of Regulatory Affairs to lead global strategy for FDA submissions (510(k), De Novo, PMA), EU MDR documentation, and international registrations.

You'll partner with R&D, Clinical Affairs, Operations, and Leadership to shape product development and regulatory approvals for capital equipment, perfusate solutions, and sterile disposables.

Qualifications

• 12+ years of progressive medical device regulatory affairs experience
• 5–7 years at the Director level
• Proven track record with FDA 510(k), De Novo, and PMA submissions, plus EU MDR
• Experience securing registrations in China (NMPA), Brazil (ANVISA), Canada, and Europe
• Strategic regulatory thinker with cross-platform experience across capital equipment, sterile disposables, and solutions
• Experience managing regulatory activities through US-based contract manufacturers

Responsibilities

• Own submission strategy for FDA 510(k), De Novo, and PMA pathways
• Lead EU MDR technical documentation and global registrations
• Serve as regulatory voice on the business leadership team
• Collaborate with R&D, Clinical Affairs, Operations, and Commercial to influence product development and approvals

Skills

FDA submissions

Regulatory strategy

EU MDR

Global registrations

Cross-functional leadership

Job description

Organ Recovery Systems in Itasca, IL seeks a Director of Regulatory Affairs to lead global strategy for FDA submissions (510(k), De Novo, PMA), EU MDR documentation, and international registrations.

You'll partner with R&D, Clinical Affairs, Operations, and Leadership to shape product development and regulatory approvals for capital equipment, perfusate solutions, and sterile disposables.