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. ...
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...
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...
Keywords: 401k, 401k match, pto, paid time off, holiday, medical, dental, health, culture, human capital, human capital management, capital management, sap, success factors, PNP, PNPCE, Infotype Modules, Infotype Decoupled Framework, LSMW, ALE/iDocs, User-Exits, BAdI’s, SmartForms, Web Dynpro, tec, ...
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 ...
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 ...
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...
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...
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...
Household Hazard Waste Program Manager responsible for growing the CleanPack and Treatment and Disposal business within an assigned territory. Assist Technical Service General Manager in ensuring that billing goals are being met. Household Hazardous Waste (HHW) Services - HHW collection programs of ...
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...
Experience as a Project Manager managing technical projects in the customer's environment. Ensure projects are delivered on-time, within budget, and remain in scope; monitor and track project dependencies. Integrate all functions and activities necessary to ensure the project/program meets client/cu...
Program Manager (DAWIA Level III Contracting). ...
The Supply Chain Strategy Program Manager acts as a change agent by leading the execution of the supply chain project portfolio. Partners with Analytics Manager and Network Optimization Manager to develop business cases for SKU rationalization and process improvements. Maintain integrated view of th...
Manages full project life cycle from project initiation to project closure. Has the ability to mentor Project Coordinators and other Project Managers. We are looking for a Senior Project Manager to join our Digital Services group within the Advisory Department. As a Senior Project Manager you will b...
Located in Germantown, MD Project Enhancement Corporation (PEC) is a technical services business focused on providing Project Management and specialized consulting services in the areas of emergency operations, nuclear incident response, nuclear safe Program Manager, Senior, Program, Manager, Techno...
The Lead Case Manager is responsible for coordinating case management and safe and timely release services, training new case managers, and supervising the work of other case managers. Proficient use of desktop and laptop computers, internet search, people management programs, smart phones and table...
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...
The incumbent supervises several Environmental Compliance Specialists (ECS), with the main purpose of ensuring compliance with and enforcement of State and federal environmental laws and regulations. The Environmental Compliance Specialist (ECS) Supervisor is responsible for overseeing the Lead Pois...
HIAS seeks a Budget & Fiscal Compliance Specialist, North America to support our North America Programs in the creation and management of budgets, as well as the management of grants and cooperative agreements from initiation to closure in the United States and overseas. Manages reporting, complianc...
Ability to support and assist project team members in the execution and implementation of a variety of project tasks particularly by providing analytic and technical support. The Northwest Fisheries Science Center has a requirement that can provide project support services at the Montlake Laboratory...
Under general supervision from a Compliance Director, the Compliance Specialist monitors CNHS's adherence to regulatory requirements and organizational policies and procedures. Experience in a healthcare compliance role or equivalent experience (Required). ...
Provides exemplary customer service by actively managing the entire design and construction project, including initiation, design, budget, and construction, by providing timely and accurate updates to the client representative regarding project status, budget and schedule. Monitor project deliverabl...
The incumbent supervises several Environmental Compliance Specialists (ECS), with the main purpose of ensuring compliance with and enforcement of State and federal environmental laws and regulations. The Environmental Compliance Specialist (ECS) Supervisor is responsible for overseeing the Lead Pois...