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...
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...
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 Labeling Specialist to join their team. ...
Kelly® Science & Clinical is seeking a Senior Regulatory Affairs Specialist for a 1-year contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA. Regulatory Affairs Senior Specialist, Global Market Protection. The Regulatory Affairs Senior Specialist is responsible f...
Key Responsibilities:Develop and implement the Quality Management System (QMS) and Technical Documentation for medical devicesCommunicate, manage, and train internal teams and external partners on regulatory and quality mattersMaintain and improve the QMS, integrate regulatory processes into busines...
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...
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...
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...
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...
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 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. ...
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,...
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, GM...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
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...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps...
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...
Leor Weinberger, director of the Gladstone-UCSF Center for Cell and Viral Circuitry, seeks a highly motivated Regulatory / Clinical Affairs Specialist to manage regulatory affairs, author and assemble IND applications, and help manage FIH studies on new antiviral gene therapeutic candidates. The pos...
ERM has an opportunity for an experienced biologist/regulatory specialist to join our thriving global consulting firm as a . Principal Biologist/Regulatory Specialist. Principal Biologist/Regulatory Specialist. Serve as Project Biologist/Regulatory Specialist for environmental impact assessment unde...
Medical manufacturer is hiring a Regulatory Affairs Labeling Specialist on a temporary basis. ...