Regulatory Compliance Specialist

4 weeks ago


Paramus, New Jersey, United States Hackensack Meridian Health Full time
Regulatory Affairs Specialist Job Description

At Hackensack Meridian Health, we strive to provide exceptional patient care and advance our mission to transform healthcare. As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with Federal, State, and Local Regulations, Good Clinical Practice (GCP), and Institutional policies and procedures.

Key Responsibilities:
  • Ensure compliance with regulatory requirements for assigned clinical trials
  • Serve as a regulatory liaison to internal and external investigators, sponsors, and regulatory agencies
  • Organize and maintain regulatory binders and ensure ongoing compliance of study-related documentation
  • Review and prepare clinical study documentation for submission to IRBs and regulatory agencies
  • Participate in the development of procedures to ensure regulatory compliance
Requirements:
  • BA/BS diploma/degree in science or healthcare field or minimum of 2 or more years of experience in a related area
  • Proficiency in Microsoft Office Suite and/or Google Suite platforms
  • Minimum of 2 or more years of extensive experience in research, including clinical research, regulatory, auditing, and interactions with an IRB

Why Join Our Team?

As a Regulatory Affairs Specialist at Hackensack Meridian Health, you will have the opportunity to work in a dynamic and collaborative environment, contributing to the advancement of healthcare and the well-being of our patients.



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