Regulatory Affairs Specialist

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;
Hyderabad, India and Shanghai, China. We are an affiliate of Honor Health, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/Rad Partners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The Regulatory Affairs Specialist is primarily responsible for assisting Compliance and Regulatory Affairs department management (e.g., Lead Regulatory Affairs Specialist, Director of Compliance and Regulatory Affairs) in executing day-to-day tasks associated with managing, maintaining and continually improving Imaging Endpoints’ regulatory systems to meet regulatory requirements. This Regulatory Affairs Specialist is a compliance and solutions oriented individual, facilitating timely and compliant document management decision making and providing regulatory support.

This individual is instrumental in achieving business and stakeholder needs with respect to document management principles and practices.

REGULATORY AFFAIRS SPECIALIST

RESPONSIBILITIES

- Regulatory Affairs Specialist coordinates and prioritizes work activities as delegated by Compliance and Regulatory Affairs Management.
- The RA Specialist reports results and updates to Compliance and Regulatory Affairs Management.
- Work with Compliance and Regulatory Affairs Management to develop robust processes and
- procedures.
- Prepare metrics and reporting to Compliance and Regulatory Affairs Management.
- The Regulatory Affairs Specialist adheres to QMS processes and procedures and provides training as necessary.
- Perform regulatory review and approval of Scientific, Clinical, QMS, and Regulatory documents.
- Reviews Project specific documentation (e.g., Image Review Charters, RPMPs, Interim and Final Reports).
- Performs regulatory review of Business proposals, RFIs, and other client facing documents.
- Understands and applies Imaging criteria assessments to support regulatory document reviews.
- Assists Compliance and Regulatory Affairs Management in coordination of work-related activities.
- Provide regulatory assistance within the regulations of investigational products and quality standards, including but not limited to 21 CFR Part 312, 314, 50, 54, 211, ICH E6(R2), Clinical Trials
- Imaging Endpoints Process Standards, GDPR, International GCP regulations, HIPAA, Risk Management, BIMO, and ISO 9001/13485.
- Interface with Scientific Affairs, Operations, and Clinical departments on regulatory issues, providing expertise and support as required.
- Assists in the development and management of IE’s Regulatory Intelligence Program.
- Assess current regulatory GCP trends in the industry and developing a process to identify, control, and maintain documents of external origin.
- Completes deviations, CAPAs, and other investigations with regulatory impact.
- Assists with creating and revising Regulatory, Clinical, and Scientific Standard Operating Procedures (SOPs).
- Interface with Compliance and Regulatory Affairs senior management to implement regulatory strategies and plans to facilitate continuous improvement of the QMS regarding regulatory affairs initiatives.
- Provide regulatory support for internal audits, sponsor audits, and regulatory inspections.
- Provide Regulatory training to IE personnel related to current industry practices and interpretation of…