The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, requires working knowledge of products under review and of relevant regulations and guidance documents. This i

Under the direction of The Fenway Institute's Associate Medical Director and the Clinical Research Operations Manager, the Study Coordinator will work with staff in the BioMedical Research Program at The Fenway Institute to support and implement clinical trials funded by a government agencies and/or industry sponsors. Please note that TFI works on multiple projects and wi

The Global RA Manager (US Regional Regulatory Lead) contributes to the Company's success by managing the US Regional and in some cases global Regulatory strategy by providing regulatory guidance to the R&D Global Core Team as well as other non R&D functions. Main Responsibilities 1) Contributes to company success with collaboration from the Regulatory TA head 2) Accountab

More Good Reasons to work for Par Unique culture There is nothing ordinary about Par Pacific a niche player in the energy space that operates in logistically complex markets. Andthere'scertainly nothing ordinary about Par Pacific people. We are driven, hardworking, entrepreneur minded professionals that love to win. If that describes you,you'llfit right in. Location, loca

Lear For You We work hard for the people who work for us. We champion our teams. We foster collaboration, inclusion, respect and excellence. What we are trying to say is we want to be more for you. We are your path to a better career, a better future, and a better you. Our teams have invented groundbreaking technologies, flawlessly manufactured millions of products and ea

Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitor

We are seeking a Trademark Docket Specialist for our Minneapolis, Denver, or Salt Lake City office. In this role, you will support all aspects of U.S. and foreign trademark, copyright and domain name docketing across Dorsey's IP offices. Are you passionate about IP? Do you thrive in a fast paced environment with excellent attention to detail? Are you a problem solver and

of The Job FNTS is seeking an experienced individual passionate about compliance audits to join our team as a Privacy & Security / Risk & Compliance Analyst. The ideal candidate is driven by identifying and reducing organizational risks through the compliance and governance program ensuring the organization meets requirements. This position functions as a team member in th

Apply strategic, analytical, and creative thinking to help promote policy issues on topics such as family caregiving, nursing home quality, health and welfare, and retirement security Research policy issues, draft documents to support advocacy efforts, and participate in team meetings and strategy discussions Attend external meetings, forums, and legislative and/or regula

Develops a state specific strategic vision for the organization that considers organizational priorities, state and local level needs and issues, and feedback from internal and external stakeholders. Mobilizes the state office team of staff and volunteers in the execution of the strategic vision. Collaborates with staff across the organization in support of the state's wo

The Compliance Analyst position assists and assures full compliance of Enovis' programs. The Compliance Analyst needs to be well versed in all of the guidelines and regulations pertaining to Enovis' compliance program, such as Health Care Professional (HCP) Interactions; Anti Bribery/Anti Corruption and Third Party Management; and Transparency & Reporting. Key Responsibil

Develops, leads, and oversees a funded portfolio of large policy relevant interdisciplinary research and implementation projects that utilize cutting edge methods (e.g., quantitative, qualitative, or mixed research methods; improvement and/or implementation science; policy analysis) in partnership with public agencies, community members, and lived experts. Oversees the de

CAMP Systems International is currently in search of a Director of International Trade Compliance! Do you have experience with International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR)? Come join our growing team! In this position, you will work to develop policies and manage internal export and import controls to ensure compliance with

As a combined organization, and is undertaking what is perhaps the central challenge of our times to help drive the transition to net zero carbon economies while ensuring that no working families, businesses, or local communities are left behind. To do that, we are the utility industry's top provider of turn key energy efficiency and grid optimization programs and product

of the Job Assist Chief Compliance Officer with daily compliance duties and serve as back up for other Compliance Department employees. The Compliance Department Analyst is responsible for assisting in the development, implementation, and monitoring and maintenance of a compliance program designed to ensure that each functional area of the bank achieves and maintains compl