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

Braun Medical Inc. ("B.Braun") has an opening for a Senior Counsel, Life Science Regulatory and Quality. The Senior Counsel, Life Science Regulatory and Quality, will support a wide variety of global regulatory and quality matters related to the design, manufacture, distribution and sale of medical devices and pharmaceuticals throughout the world, including product submis

Provide quotes and develop agreements for Government Accounts based on direction provided by the US Sales Organization, revising as needed throughout the negotiation process. Amend and restructure existing group customer agreements when required. Track the status of new offers to measure win rates and cycle times. Cultivate a strategic partnership with the Sales Organizat

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

The Compliance Manager works with the Director of Compliance and Chief Compliance Officer to support our Global business on compliance matters relating to adherence to relevant policies, codes, laws, and regulations impacting business operations. The Compliance Manager will assist with various aspects of our compliance program, including compliance training, auditing and

Newport, an Ascensus company, helps employers offer their associates a more secure financial future throughretirement plans,insuranceandconsulting services. Newport offers comprehensive plan solutions and consulting expertise to plan sponsors and the advisors who serve them. As a provider and partner, Newport is independent, experienced, and responsive. Job Summary Assist

Implementation Procurement Associate McKinsey Implementation Who You'll Work With You'll be working with McKinsey Implementation, a rapidly growing capability for our firm, in one of our offices in North America. As a member of MI, you'll work closely with our client project teams, providing end to end support to ensure the clients are able to deliver and sustain the full

Genesys empowers more than 7,500 organizations in over 100 countries to improve loyalty and business outcomes by creating the best experiences for customers and employees. Through Genesys Cloud, the #1 AI powered experience orchestration platform, Genesys delivers the future of CX to organizations of all sizes so they can provide empathetic, personalized experiences at sc

unlocking global understanding. As a unique, world leading provider of technology enabled language, content, and intellectual property services, we remove the barriers to communication to make global connection possible. Our unrivalled experience and deep understanding of language have been developed over more than 60 years. As we look to shape the future, our ambition is

A valid driver's license and full time usage of reliable transportation are required. Driving is an essential function of the job and Motor Vehicle Records may be checked as part of the hiring process or at any time during employment Required to carry sufficient motor vehicle insurance Accurate and efficient typing capabilities (40+ WPM recommended) and ability to work wi

/JOB PURPOSE Manages all regulatory activities for new development programs, pre IND through BLA/NDA and post approval. Responsible for developing and implementing global regulatory strategies encompassing clinical, non clinical and CMC disciplines. Provides expertise in translating regulatory requirements into practical, workable plans. Essential Duties And Responsibiliti

The Specialized Tax Services (STS) Tax Credits & Incentives Senior Associate is responsible for leading or supporting our services to identify, calculate, document, and support on examination by tax authorities Business Incentive Group (BIG) tax credits and other tax incentives. In this role, and utilizing their educational knowledge, experiences, communication, and organ

The FDA Center for Tobacco Products requires the assistance of minors ages 16 17 and those under age 18 20 to attempt the purchase of tobacco products from local tobacco retailers. The goal of the program is to ensure tobacco retailers are complying with Federal laws and regulations that prevent them from selling tobacco products to minors. This will be a part time, posit

Manage all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements. Lead cross functional groups across the organization in the development of global regulatory strategy to complete developmental and post approval regulatory submissions. Define contributions for submissions, communicate to functional con

The Practice Solutions Consultant, a key member of the Advisor Sales & Wealth Consulting distribution team, will be responsible for working directly with financial advisors to increase sales and platform adoption of Envestnet's offerings. This individual will work with a Practice Solutions Director to support, promote and distribute Envestnet solutions to advisors across