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. ...
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 Affairs Specialist. ...
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...
A company is looking for a Regulatory Compliance Specialist. ...
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...
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 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...
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 ...
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...
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. ...
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...
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...
Senior International Regulatory Operations Specialist. As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and environment. Assist in the development of regional regulatory strategy and update str...
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. ...
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...
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...
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 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...