Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
Assist higher level project manager with allocation of resources (staffing, facilities, and budgets) on the effort. Work with project managers, to provide effective and efficient management of the contractor’s effort. Serves as the technical point of contact for the Program Manager and team members....
Responsible for the operational planning, establishment, execution, and evaluation of a multifaceted program/project typically consisting of a set of closely related subprograms or associated activities, after the government approves the work requirement. Develop, write, update, revise, and maintain...
Responsible for providing services to the Compliance Group to ensure the corporation's compliance with relevant laws, executive orders, directions, and regulations governing mission activities. Use compliance-related tools to audit, monitor, or gather oversight and compliance data. Coordinate compli...
The successful candidate will perform the full range of Fitness-for-Duty Specialist duties and other duties as assigned. ...
Provide specific examples in applying risk insights for regulations, regulatory guides, industry codes, standards, and other criteria in collaboration with internal and external stakeholders to develop solutions to technical, regulatory, and policy issues. Emergency Preparedness Specialist duties. S...
As a Personnel Security Specialist, you will play a crucial role in supporting the Chief of the Personnel Security Branch in implementing the NRC Personnel Security program. ...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
The incumbent will serve as an inter-agency consultant on compliance related matters. This person will review to ensure compliance of Davis Bacon certified payrolls and customer Reasonable Accommodation requests. Will manage and monitor compliance reporting, investigate, follow-up and follow through...
Regulatory Affairs Manager in the Gaithersburg, MD area. As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives. The RAM contributes to regulatory submission strategy, ide...
Are you an experienced project manager with a passion for HVAC and mechanical engineering? Ready to take your career to the next level with a leading company? This is your chance to step into a pivotal role that will shape the future of cutting-edge projects!What You’ll Be Doing: Lead and Innovate: ...
We are seeking a Senior Level Regulatory and Legislative Specialist in Rockville, MD. The Senior Level Regulatory and Legislative Specialist will leverage extensive experience in developing and managing Federal programs related to the U. The specialist will play a pivotal role in creating and implem...
We are seeking a highly skilled Senior Sales Project Manager for our client, a leader in the HVAC/Mechanical industry. Project Documentation: Organize and maintain accurate project documentation for efficient reference and management. You will work closely with various internal teams to ensure proje...
Assist in advising clients on compliance with federal and state laws, rules, and regulations. Help create and maintain essential compliance tools for clients and internal teams. Develop and maintain compliance resources for clients and internal staff, drawing on your understanding of relevant regula...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
Overview: The Senior Risk and Compliance Analyst is internal to Inovalon and part of the Security, Risk and Compliance department that partners with Technology, business groups, and project teams to perform risk and compliance activities and audits for applications, infrastructure, and vendor/third ...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, regula...
Performance Management Data Analyst ) who will be responsible for the compliance monitoring of the retirement benefit process of the Montgomery County Employee Retirement Plans. Overseeing the third party recordkeeper, related to corrections of employee accounts, outside agency contribution reconcil...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vi...
Project Manager -Medical Equipment Installations. ...
The Project Manager will provide oversight of all aspects of field and/or task-level project performance. This Project Manager will need to recommend action to direct the analysis and solutions of problems while exercising independent judgement, as well as a high level of analysis in solving non-rou...
ICF is currently seeking an Associate Program Manager and Commercial HVAC, Lighting, or food service technical expert to support our energy efficiency programs in Maryland. Midstream Commercial Programs. Successful candidate will lead the strategy, development, and management of commercial midstream...
Center Director, Center for Devices and Radiological Health. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective. Demonstrated knowledge and ...
Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation. Associate Regulatory Affairs Director. Contribute to regulatory submission strategy, identifying submission risks and opportun...
Regulatory Affairs Manager - (MGRRA_COMPANY_1). Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure com...