Manager Regulatory Affairs (NJ)

A company is looking for a Manager Regulatory Affairs (ACT). Key Responsibilities Lead cross-business Regulatory programs for Acute Care Therapy medical device businesses Oversee the EU MDR implementation program, ensuring timely compliance and reporting Manage the implementation and maintenance of an electronic IFU portal for medical devices Required Qualifications Bachelor's Degree required; advanced degree preferred Minimum of 6 years of experience in medical device regulatory affairs Experience with EU MDR and international product registration requirements Prior experience with medical device labeling requirements Experience leading complex projects or programs

Mar 3, 2025 - 17:47

A company is looking for a Manager Regulatory Affairs (ACT). Key Responsibilities Lead cross-business Regulatory programs for Acute Care Therapy medical device businesses Oversee the EU MDR implementation program, ensuring timely compliance and reporting Manage the implementation and maintenance of an electronic IFU portal for medical devices Required Qualifications Bachelor's Degree required; advanced degree preferred Minimum of 6 years of experience in medical device regulatory affairs Experience with EU MDR and international product registration requirements Prior experience with medical device labeling requirements Experience leading complex projects or programs