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...
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...
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 Compliance Specialist. ...
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 Regulatory Affairs Specialist. ...
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 Labeling Specialist to join their team. ...
We are hiring a Senior Regulatory Affairs Specialist for our Diagnostics Regulatory Affairs team who will be responsible for new product development, on-market, and international regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies. Autonomously...
SAP, RQS, Genesis) to support DMFI Regulatory activities, which includes helping develop Regulatory policies and procedures to be in compliance with evolving state and federal regulations (i. Provide regulatory guidance and approval in managing label changes relative to formula updates under trainin...
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Ability to interpret and apply regulatory requirements. Offer regulatory direction and interpretation on team activities. ...
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...
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...
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 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...
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,...
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...
Medical manufacturer is hiring a Regulatory Affairs Labeling Specialist on a temporary basis. ...
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...
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 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. ...
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...