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...
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...
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...
Responsible for regulatory activities, including product registrations, impact assessment, etc. PAC regulatory submissions in Medical Devices or Pharmaceutical industries. ...
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...
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. ...
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...
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...
About the opportunity SWCA Environmental Consultants is seeking a Senior or Principal Biologist - Regulatory Specialist with experience in natural resources and aquatic permitting, natural resource management, biological studies, and mentoring for our Northern California Natural Resources and Ecolog...
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...
The Staff/Principal Regulatory Affairs Specialist will function as a subject matter expert and will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U. Represent regulatory in clinical program teams and communicate regulator...
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...
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...
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...
Responsible for regulatory activities, including product registrations, regulatory 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...
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...
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...
The Staff Regulatory Specialist’s primary responsibility is to prepare regulatory submissions, filings, dossiers, Letters to File, and to provide recommendations to the research and development teams during the product development to ensure compliance with regulatory requirements. A Day In The Life ...
Accreditation and Regulatory Compliance Specialist - Regulatory Compliance (1. 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 enterpri...
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 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...
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 ...
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...
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...