Senior Regulatory Affairs Specialist

Job Description

Senior Regulatory Affairs Specialist Class III | 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 sitting within Regulatory Affairs. You will lead regulatory strategy and submissions for assigned devices across the US and international markets, working closely with Manufacturing, Quality, R&D, Operations, and Clinical teams. You will report to the Director of Regulatory Affairs.

What you will own:

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• Leading pre and post market regulatory activities for assigned devices and projects
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• Running regulatory impact assessments for design, labelling, packaging, supplier, and manufacturing changes
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• Preparing and coordinating submissions, including PMAs, PMA supplements, amendments, and annual reports
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• Supporting regulatory authority interactions, including correspondence and responses to information requests
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• Reviewing verification, validation, and risk management documentation
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• Contributing to process improvements and regulatory intelligence
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• Supporting and training junior team members
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What you must have:

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• Bachelor's degree or higher in Engineering, Life Sciences, or a related field
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• 5+ years of regulatory affairs experience in medical devices, including US Class III
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• Working knowledge of regulations outside the US (Canada, Europe, UK)
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• Experience assessing product changes against standards (ISO, ASTM)
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• Strong technical writing skills
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• Track record of successful submissions in the US and EU
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• Experience working cross-functionally with Manufacturing, Quality, R&D, Operations, and Clinical
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