Regulatory Affairs Specialist

About This Role

This role involves assisting the Compliance and Regulatory Affairs department in managing, maintaining, and continually improving regulatory systems to meet requirements. The specialist facilitates timely and compliant document management decisions, provides regulatory support, and is instrumental in achieving business and stakeholder needs related to document management principles and practices.

Responsibilities

• Coordinate and prioritize work activities as delegated by Compliance and Regulatory Affairs Management
• Report 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
• Adhere to QMS processes and procedures and provide training as necessary
• Perform regulatory review and approval of Scientific, Clinical, QMS, and Regulatory documents
• Review Project specific documentation (e.g., Image Review Charters, RPMPs, Interim and Final Reports)
• Perform regulatory review of Business proposals, RFIs, and other client facing documents
• Understand and apply Imaging criteria assessments to support regulatory document reviews
• Assist 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
• Assist in the development and management of IE’s Regulatory Intelligence Program
• Assess current regulatory GCP trends in the industry and develop a process to identify, control, and maintain documents of external origin
• Complete deviations, CAPAs, and other investigations with regulatory impact
• Assist 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 FDA guidance, regulations, and standards
• Assist the Compliance and Regulatory Affairs department in establishing and reporting quality and regulatory metrics