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 understanding in the breadth of science applicable to FDA’s m...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Regulatory Affairs team is responsible for obtaining and maintaining regulatory approvals for Certis Biologicals li...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
The Regulatory Affairs Specialist is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory aspec...
Quality/Risk Management US Regulatory Affairs. The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
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 ...
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...
We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States. The Food and Drug Administration is the regulatory, sci...
Our offerings include health, life, disability, financial, and retirement benefits, as well as paid leave, professional development, tuition assistance, work-life programs, and dependent care. Our recognition awards program acknowledges employees for exceptional performance and superior demonstratio...
Three years of experience in conducting quality assurance (form, content, grammar and requirement compliance) of systems and software processes, PCA, documentation, and verification audits. ...
Primary responsibilities are the management of cost, schedule, and technical performance of company programs or subsystems and include, but are not limited to: * Supporting a program organization as a Deputy Program Manager, that effectively addresses customer requirements and incorporates the neces...
Technical Writer, Facilitation, Document Preparation, Document Revision, Technical Publications, Technical Drawing. We're searching for talented Technical Writer. As an NSM Technical Writer on our team you will support the customer's effort to improve the nation's Cybersecurity of the Federal Inform...
The Deputy Program Manager (DPM) will be responsible for assisting the Program Manager (PM) with the coordination of all program-related activities to include providing liaison with the customers and representing program interests within the Oceaneering. The DPM reports to the PM and may be assigned...
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...
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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...
Education and Experience: .Bachelor’s Degree Preferred.Preference for degree in computer science, information systems, data science, or software or computer engineering.Eight (8) years’ experience supporting SDLC environments using tools such as .Net Framework, Visual Studio, HTM...
Education and Experience: .Bachelor’s Degree Preferred.Preference for degree in computer science, information systems, data science, or software or computer engineering.Primary responsibilities .Conduct business analysis and identify business objectives and requirements.Elicit,...
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...
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 ...
As an Information System Security Manager. Your main responsibility will be to ensure classified systems follow government and APL regulations while still meeting program demands and operating in an accredited state. You will support the Chief Information Security Officer (CISO) and the Chief of Cla...
The Senior Analyst identifies, interprets, and programs restrictions into the Charles River compliance system to support automated compliance testing across all portfolios managed by T. Investment Compliance is a global function responsible for ensuring compliance with regulatory, prospectus, client...
This finance firm with ties to the real estate industry is seeking a project and data-minded professional to spearhead project timelines, deliverables, and management across a high-functioning team. This team is seeking a project performer with previous contracts, real estate, or construction-relate...