Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Regulatory Affairs Specialist, Medical Device. Handling the regulatory assignments with a good understanding of medical process standards ISO13485, ISO14971, IEC 62304, and IEC 62366. Regulatory strategy preparation. Regulatory assessment for the Electro-mechanical devices. ...
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...
Job Duties:* * Lead the OU on all supply chain related efforts across multiple sites * Cost Account Manager (CAM) for over $600M of material budgets * Ensure supplier priorities are aligned with program needs and implement mitigation plans and corrective actions when material becomes non-supporting ...
Three (3) years of experience in conducting quality assurance (form, content, grammar and requirement compliance) of systems and software processes, PCA, documentation, and verification audits required. ...
Global Trade Compliance Specialist. Global Trade Compliance Specialist. This position focuses on implementing international trade compliance activities into daily business operations, conducting compliance assessments, and working with a variety of internal stakeholders to ensure that the proper pro...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
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...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
Reporting to the Academic Director, the Program Manager for Fellowships works with the Center's fellows to advance their position as thought leaders in the field by collaboratively developing, producing, and disseminating new ideas and practices in the field of public innovation, along with other re...
Responsible for successful delivery of a program to a customer; or manage performance of a task or project as part of a larger program under direction of another PM. Lead a cross functional team, to include but not limited to, systems engineers, software and hardware integrators, software developers...
The GMAS Project Manager is responsible for the delivery of large and/or complex projects for the GMAS backend system (Global Merchant Accounting System). Projects requiring a PM are primarily projects large enough for a business case, have multiple system impacts and/or projects with complex GMAS r...
The incumbent will coordinate and develop data tracking processes at the discretion of the QA Supervisor with respect to Child and Family Service Reviews, Continuous Quality Improvement, program data collection and tracking, etc. ...
Global Trade Compliance Specialist. This position focuses on implementing international trade compliance activities into daily business operations, conducting compliance assessments, and working with a variety of internal stakeholders to ensure that the proper processes, procedures, and authorizatio...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
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...
Century Engineering is seeking a responsible candidate for program and contract management services working under the guidance of an experienced program manager in Anne Arundel County. The successful candidate will become part of a team to evaluate, develop, coordinate and manage multi-year programs...
We have an urgent requirement for a Technical Project Manager with FACET experience. Technical Project Manager FACET exp. The Technical Project Manager will manage a team that deals with enrollment, billing, and invoicing. This Technical Project Manager will handle the development and execution of t...
The Compliance Analyst I - Global Control Room will ensure that Stifel complies with outside regulatory requirements and internal policies and procedures related to the Global Control Room, with focus on employee trading and outside accounts. Experience in the financial industry, compliance, or othe...
The Project Manager is an individual contributor accountable for project budgets, team performance, and developing strategic plans to implement projects for various organizations. Responsible and accountable for overall project performance for projects, subprojects, processes, new technology program...
Chicago IL (81013), United States of America, Chicago, IllinoisAgile Program Lead, Senior ManagerIn the Agile Program Lead role, you''ll ensure your teams'' delivery success by leveraging the appropriate Agile methodology (Scrum/Kanban/etc. Fosters innovation with practices and frameworks through ex...
Providing strong leadership, mentorship, and supervision to Project Managers, Field Managers, Project Engineers, and subcontractors. As a Senior Project Manager for STRUCTURAL, you will be responsible for managing complex construction projects that make our nation’s structures stronger and last long...
Minimum 3-5 years' experience as a Project/Civil Engineer or Project Manager or Estimator. Sr Project Manager Opportunity. ...
Develops Compliance Hotline statistical data for reporting to the Audit and Compliance Committee of the Board of Directors, the Executive Compliance Committee, the Affiliate Compliance Officer Committees and other meetings as requested. Works collaboratively with the Compliance Director in compiling...
International Trade Compliance Analyst. The qualified applicant will become part of Northrop Grumman's International Trade Compliance organization, supporting the Land & Maritime Sensors portfolio, working to ensure compliance with export laws and internal processes that support foreign policy and p...