Equity Medical · 2 hours ago
Regulatory Specialist
NYC Metro Area
Full-time
Onsite
Mid LevelEquity Medical, LLC is a multi-state clinical trial research company committed to diversity and inclusion. The Regulatory Specialist will support the regulatory affairs team to ensure compliance with regulatory requirements for clinical research projects, prepare and submit regulatory documents, and collaborate with teams across locations.
Hospital & Health Care
Responsibilities
As a Regulatory Specialist, you will play a key role in supporting the regulatory affairs team to ensure compliance with all applicable regulatory requirements for clinical research projects
You will assist with the preparation, submission, and tracking of regulatory documents, as well as maintaining up-to-date records and files for clinical trials
You will report directly to the Regulatory / Quality Assurance Manager and collaborate with both the New York and Kentucky teams to ensure efficient and compliant regulatory processes
Key responsibilities will include preparing and submitting regulatory documents to authorities (e.g., IRB, FDA), tracking deadlines, and managing submissions to ensure timely compliance
Maintain and organize regulatory files, including study-specific documents, informed consent forms, and investigator brochures
Monitor regulatory updates and changes in guidelines to ensure compliance with local, state, and federal regulations
Coordinate with study sponsors and internal teams to ensure regulatory documents are complete, accurate, and submitted on time
Support regulatory correspondence with study sponsors and agencies, including responses to inquiries
Assist with regulatory audits and inspections as required, ensuring documents are in order and facilitating the process when audits occur
Perform other duties as assigned
Qualification
Required
Previous experience as a Clinical Trial Regulatory Specialist in pharma-sponsored interventional studies
Must already be located in NYC Area
Willingness to work in a fast-moving, dynamic, fun, patient-centered environment
Self-starter and lifelong learner
Company
Equity Medical
Offices: Manhattan, Bronx, and Bowling Green KY (more on the way!) At Equity Medical, our mission revolves around you – our valued patients.
Founded in 2023
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase