A company is looking for a Regulatory & Compliance Specialist in the healthcare ecosystem. Key Responsibilities:Track state and federal legislation and regulations affecting clientsUpdate bills and rules in the online softwareMonitor Board of Pharmacy websites for relevant informationRequired Qualif...
The Regulatory Specialist is responsible for creating, maintaining, and coordinating regulatory documents and activities for clinical research studies at Flourish Research, ensuring compliance with SOPs, federal regulations, ICH, GCPs, IRB requirements, and sponsor protocols while collaborating with...
Key Responsibilities:Plan, coordinate, and drive the development and evaluation of regulatory strategies and submissionsManage resources and provide regulatory leadership and mentoringConduct quality audits, develop management systems, and represent projects at various meetingsRequired Qualification...
The Entry-Level Regulatory Specialist supports the Regulatory Affairs team in ensuring compliance with applicable laws, regulations, and standards governing products or processes within the organization’s industry. Maintain regulatory databases, document control systems, and filing systems to ...
A company is looking for a Global Regulatory Affairs Specialist. ...
The RA Specialist will be self-directed and motivated and be responsible for preparing global regulatory submissions and obtaining and maintaining approvals necessary to market products world-wide. Review and approve labeling for compliance to standards, guidelines, regulations, and regulatory. Bach...
Submit Initial Regulatory Documents to appropriate personnel as stated in cover letter of the regulatory package. Prior to study commencement, meet with designated Study Coordinator(s) to provide them with regulatory documents for insertion in the Regulatory Binder. Receive and set up files on all p...
Regulatory Affairs Specialist to join our team. This role involves collaboration across various departments, providing regulatory guidance, and managing submissions to regulatory bodies. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve t...
The Office of Human Subjects Protection within the Office of Vice President for Research seeks to fill the Regulatory Support Specialist, IRB Administrator position. Advises and assists faculty with preparing and maintaining pre-submission through post-approval IRB-related regulatory files, includin...
Submit Initial Regulatory Documents to appropriate personnel as stated in cover letter of the regulatory package. Prior to study commencement, meet with designated Study Coordinator(s) to provide them with regulatory documents for insertion in the Regulatory Binder. Receive and set up files on all p...
Working Title: REGULATORY SPECIALIST I. Must be able to independently exercise professional judgment when providing licensure and regulatory information to licensees, applicants, and consumers. Serves as administrative assistant to the Regulatory Supervisor over licensing, including assisting with U...
The Specialist, Quality Systems and Regulatory Compliance will have the following qualifications:. ...
In coordination with Regulatory Affairs management, this role will assist in the development of regulatory strategy, manage the execution of regulatory plans, and perform other activities that lead to and maintain device registrations for Arthrex’s medical devices. Arthrex is actively searching for ...
The Regulatory Specialist will report to Accreditation and Regulatory Management leadership. A Regulatory Specialist plays a vital role in ensuring delivery of high-quality healthcare services by performing audit activities across the healthcare system. Clinical processes and behaviors important to ...
Essential Duties and Responsibilities:.Organizes, documents, and coordinates ongoing projects in Quality Systems to assure the Arthrex QMS meets all applicable requirements.Coordinates and manages quality systems records including any of the following: Corrective and Preventive Actions (CAPA), Nonco...
Obtain necessary information internally and externally (vendors, customers, regulatory agencies, etc. Ability to work in a safe professional manner adhering to all regulatory requirements including, OSHA, EPA, State and Federal regulations. ...
Submit Initial Regulatory Documents to appropriate personnel as stated in cover letter of the regulatory package. Prior to study commencement, meet with designated Study Coordinator(s) to provide them with regulatory documents for insertion in the Regulatory Binder. Receive and set up files on all p...
Working Title: 68025178 - REGULATORY SPECIALIST I. ...
The role you’ll contribute:** Clinical Regulatory Specialist – Emergency Department (CRSED) is responsible for all audits, patient chart reviews and data collection in compliance with hospital governing agencies. Prioritizes, compiles, and maintains regulatory data as required for system initiatives...
Working Title: OPS REGULATORY SPECIALIST II - 64802122. The incumbent will work in a professional, administrative setting and perform duties similar to customer service representatives, school registrars, medical records, billing, or coding specialists; data entry clerks, or other positions who ensu...
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Contributes to the FDA regulatory submissi...
Regulatory Support Specialist, IRB Administrator. Office of Vice President for Research seeks to fill the Regulatory Support Specialist, IRB Administrator position. Advises and assists faculty with preparing and maintaining pre-submission through post-approval IRB-related regulatory files, including...
The Tax & Regulatory Compliance Specialist plays a pivotal role in ensuring the organization's adherence to tax laws, regulations, and reporting requirements. The specialist collaborates closely with internal teams, external auditors, and regulatory authorities to maintain accurate financial rec...
Overview: The Entry-Level Regulatory Specialist supports the Regulatory Affairs team in ensuring compliance with applicable laws, regulations, and standards governing products or processes within the organization’s industry. Data Management: Maintain regulatory databases, document contro...
We are actively hiring for a Regulatory Specialist at our Miami site in Little Havana! The Regulatory Specialist is responsible for creating, maintaining, and coordinating regulatory documents and activities for clinical research studies at Flourish Research, ensuring compliance with SOPs, federal r...