Director of Regulatory Affairs : Class II/III Medical Devices

Director of Regulatory Affairs | Organ Recovery Systems | Itasca, IL

Since 2003, Organ Recovery Systems has protected the donor's gift. Their LifePort Kidney Transporter has preserved over 275,000 kidneys and set the standard for hypothermic machine perfusion worldwide.

Now they're hiring the regulatory leader who sets global strategy across three technology platforms, capital equipment, perfusate solutions, and sterile disposables, and keeps ORS in market across the US, EU, China, and Brazil.

This is a strategic seat with real teeth. You'll own submission strategy for FDA 510(k), De Novo, and PMA pathways, lead EU MDR technical documentation and global registrations, and serve as the regulatory voice on the business leadership team.

You'll report directly to the SVP of Quality and Regulatory, sit alongside the Quality Operations and Quality Systems Directors, and partner with R&D, Clinical Affairs, Operations, and Commercial to shape how products get built and get approved.

What ORS needs:

• 12+ years of progressive medical device regulatory affairs experience, with 5 to 7 years at the Director level
• Demonstrated success with FDA 510(k), De Novo, and PMA submissions, plus EU MDR
• Proven track record securing and maintaining registrations in China (NMPA), Brazil (ANVISA), Canada, and Europe
• Strategic regulatory thinker who can navigate standards across capital equipment, sterile disposables, and solutions; deep product-specific history matters less than the ability to apply standards across all three
• Experience managing regulatory activities through a network of US-based contract manufacturers

What makes this role different:

• You're setting global strategy for technology that keeps organs viable between donor and recipient, not chasing paperwork after the fact
• Perfusion, organ preservation, transplant, or cardiovascular device background is a strong plus here
• Warning letter or consent decree experience is genuinely valued; the SVP has been through both and knows what that kind of judgment looks like under pressure
• Succession path is open for the right candidate