Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist (Software) | Organ Preservation Technology Hybrid (New Jersey) | Competitive Salary + Bonus + Benefits

A commercial stage organ technology company, pioneering normothermic machine perfusion. Their flagship platform has supported thousands of liver transplants worldwide, keeping donor organs viable outside the body for longer and improving transplant outcomes.

This is a Senior Regulatory Affairs Specialist role focused on Digital Health, Software, Cybersecurity, and Electromechanical device projects. You will prepare submissions for the FDA and Health Canada and work closely with cross-functional teams. You will report to the Director of Regulatory Affairs, Software and Innovation.

What you will own:

• Providing regulatory support for Digital Health, Software, Cybersecurity, and Electromechanical projects
• Supporting pre-market and post-market regulatory activities
• Preparing submissions (IDE, IDE Supplements, PMA, PMA Supplements) for FDA and Health Canada
• Interfacing directly with FDA and Health Canada on assigned projects
• Tracking regulatory changes in the US and Canada
• Communicating regulatory updates to internal and external stakeholders
• Preparing summaries and visualizations for senior management

What you must have:

• Bachelor's degree or higher in Engineering, Life Sciences, or a related field
• 3 to 8 years of relevant regulatory experience with Class II/III devices and software
• Working knowledge of FDA processes for medical device compliance
• Experience with SaMD, SiMD, cybersecurity, or electromechanical products
• Strong regulatory strategy and submission writing skills
• Understanding of GMP compliance
• Experience working cross-functionally with Manufacturing, Quality, R&D, Clinical, and Marketing