Reporting to the Director, Regulatory Affairs & Compliance, the Regulatory Affairs Specialist supports routine to complex activities in the Compliance and Regulatory Affairs Department. Submit regulatory reports such as annual Timely Access Report. Review regulatory reports for trends and refer conc...
Under the direction of the Clinical Research Manager, and in compliance with University and Department policies and federal and state regulations, the Regulatory Specialist will work closely with investigators, their study teams, regulatory personnel, and sponsor partners to draft and manage study d...
The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensuring adherence to regulatory standards across diverse areas. The Ambulatory Regulatory Compliance Specialist has a pivotal role within the organization and is responsible for ensurin...
The Department of Orthopaedic Surgery is looking for a candidate experienced in high volume clinical trials, protocol development, and regulatory submissions to work with investigators to prepare, submit, provide guidance, and manage the regulatory submissions. Under the direction of the Research Ad...
A company is looking for a Senior Regulatory Compliance Specialist. ...
Palo Alto, CA seeks Regulatory Affairs Specialist: Examine, evaluate & investigate eligibility for or conformity with laws & regulations & perform other compliance & enforcement inspection & analysis activities. ...
A company is looking for a Labeling Specialist to join their team. ...
JCW is working on an exciting search for Regulatory Affairs Specialist III for global Biotech who is expanding their growing team. In this role you will play a key role in planning, managing, and tracking of regulatory submissions and documentation for the production of biological medicines. Account...
A company is looking for a Regulatory Specialist - Dental Operations. Key Responsibilities:Support external and internal regulatory reporting, surveys, audits and investigations impacting dental operationsMonitor incoming regulations and share regulatory guidance with dental operationsPerform monito...
We are seeking a Senior Regulatory Permitting Specialist with expertise in aquatic resource permitting to join the team at a natural resources focused consulting firm. Join a dynamic, employee-owned environmental consulting firm based in the vibrant San Francisco Bay Area that specializes in providi...
We are looking for a detail-oriented clinical professional to join our growing Regulatory team as a Clinical Regulatory Coordinator (CRC) or Clinical Regulatory Specialist (CRS). Clinical Regulatory Coordinator/ Specialist. Work closely with Clinical Operations and Regulatory Affairs to ensure compl...
Senior Regulatory Affairs Specialist - Remote Based - West Coast. This Senior Regulatory Affairs Specialist will have an opportunity to work on new to market technology that is improving the field of diagnostic imaging and saving patient lives. Confer with other Regulatory Affairs subject matter exp...
The Senior Specialist directly supervises the Regulatory Specialists. Senior Ethics & Compliance Specialist Regulatory Support Manager. The Senior Ethics & Compliance Specialist/Regulatory Support Manager is a subject matter expert on FDA regulations, the university's policies, processes, an...
Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. Provide expert regulatory advice during the product design and development phases, ensuring reg...
The Federal Energy Regulatory Commission (FERC) is ranked within the top 5 mid-size agencies through the Partnership for Public Service’s Best Places to Work in the Federal Government Rankings! This Program Specialist position is located in the Office of Public Participation. To view the eligibility...
Ensure all regulatory communications/updates are received, summarized, catalogued, disseminated and acted upon. Record and maintain all client communication in accordance with company policy and regulatory requirements. ...
In collaboration with the Director of Accreditation, The Accreditation and Regulatory Compliance Specialist manages all aspects of accreditation, regulatory and hospital licensure compliance across the healthcare enterprise. Identifies opportunities for improvements based on evidence based practices...
In collaboration with the Director of Accreditation, The Accreditation and Regulatory Compliance Specialist manages all aspects of accreditation, regulatory and hospital licensure compliance across the healthcare enterprise. Identifies opportunities for improvements based on evidence based practices...
Description: Recognized content expert in area relevant to the work of the Dept.Oversees project work & staff on work related to area of expertise.Responsible for providing relevant content expertise to project leads & staff in support of project work.Builds & maintains key relationships w/ clients ...
Prefer some knowledge of Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs,...
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Provides regulatory guidance and defines regulatory strategy for digital products...
Prefer some knowledge of Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GM...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Prefer some knowledge of Regulatory and/or Quality Systems history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Principles and requirements of promotion, adv...
Regulatory Affairs Specialist will be responsible for assisting and supporting core regulatory affairs activities for the business, in addition to supporting advertising, promotional and standards review. Provide expert regulatory advice during the product design and development phases, ensuring reg...