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...
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...
Responsible for regulatory activities, including product registrations, impact assessment, etc. PAC regulatory submissions in Medical Devices or Pharmaceutical industries. ...
Regulatory Affairs Specialist III - APAC. Advises project groups on preliminary or fully assessed regulatory strategies and Implements Division Regulatory Strategy in specific product-related activities. Provides regulatory direction on team activities. Applies basic regulatory understanding to supp...
Our client has a unique opportunity for a highly skilled Principal Regulatory Specialist to join a growing team working on novel technology in the Neurological/Spine space. Lead regulatory strategy and submissions for Class 2 & 3 products, including PMA and 510(k) applications. Develop and execute r...
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...
Responsible for regulatory activities, including product registrations, regulatory impact. Experience Background (Any): APAC regulatory submissions in Medical Devices or Pharmaceutical industries. ...
This Senior International Regulatory Operations Specialist will work on-site at our Alameda, CA location in the Diabetes Care Division. As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure efficient and compliant business processes and envi...
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. ...
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...
Role: Regulatory Specialist II<br /> Location: Alameda,CA- 94502<br /> Duration: 12 Months </div> <div> <div>Job Description </div> <div> <ul> <li> Responsible for regulatory activities, including product registrations, impact assessment, etc....
Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Handles regulatory activities involved in documentation...
This Regulatory Affairs Specialist III - APAC will work out of our Alameda, CA, location in the Diabetes Division. Advises project groups on preliminary or fully assessed regulatory strategies and Implements Division Regulatory Strategy in specific product-related activities. Provides regulatory dir...
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...
Regulatory Affairs Specialist III - APAC. Advises project groups on preliminary or fully assessed regulatory strategies and implements Division Regulatory Strategy in specific product-related activities. Provides regulatory direction on team activities. Applies basic regulatory understanding to supp...
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. ...
Regulatory Affairs Specialist III - APAC. Advises project groups on preliminary or fully assessed regulatory strategies and Implements Division Regulatory Strategy in specific product-related activities. Provides regulatory direction on team activities. Applies basic regulatory understanding to supp...
Regulatory Affairs Specialist III - APAC. Advises project groups on preliminary or fully assessed regulatory strategies and Implements Division Regulatory Strategy in specific product-related activities. Provides regulatory direction on team activities. Applies basic regulatory understanding to supp...
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...
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...
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...
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...
Senior International Regulatory Product Specialist – Diabetes Care (on-site). 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 environ...