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

Product Technology Senior Analyst Job Locations US WI Merrill | US WI Milwaukee | US WI Madison | US PA Mechanicsburg ID 20243379 Category Product Type Regular Full Time Introduction Looking to join a vibrant organization that makes a difference? As part of the Church Mutual team, you'll work with some of the most experienced and knowledgeable people in the industry and a

& Essential Functions include Data Integration and Analysis. Supporting various data integration efforts by performing data entry, editing, and/or validation tasks. Maintaining integrity related databases and tracking tools. Providing data maintenance support as directed by, and with oversight from, Integrity department staff. Performing basic data analytics and visualizat

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

As aWorkforce Experience Partner,your expertise in applying Design Thinking to Employee Experience, Ambient Employee Listening, Qualitative Data Analytics as well as Strategic Workforce Planning will be used to support our teams working in a global and diverse environment. In this position, you will report to the Global Workforce Experience Leader and will have the autono

Lead Chatham's US Regulatory and Documentation practice, a unified team supporting all of our client sectors in navigating applicable regulations Collaborate with the International Regulatory and Documentation practice lead to ensure an appropriate degree of alignment in processes, priorities, and talent development Partner effectively with stakeholders outside of direct

Site Name USA Maryland Rockville, USA Pennsylvania Upper Providence Posted Date Apr 11 2024 Are you looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a

Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation inspiring complex change, enabling organizations to grow, building competitive advantage,

Focus on analyzing various business operations and performances. Scrutinize data and metrics to understand trends and provide actionable insights that help in strategic decision making and improving overall business efficacy. Create weekly and monthly reports with internal KPIs to report out to leadership. Will also be responsible for developing and creating ad hoc report

Data Management and Quantitative Analysis IC1Under direct guidance, works with internal and external datasets and client reference data and provides analysis in the development of statistical, financial and/or econometric models for analyzing asset performance, securities data, derivative pricing, risk exposure or other sophisticated concepts. Provides analytical support

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

Who We Are Boston Consulting Group partners with leaders in business and society to tackle their most important challenges and capture their greatest opportunities. BCG was the pioneer in business strategy when it was founded in 1963. Today, we help clients with total transformation inspiring complex change, enabling organizations to grow, building competitive advantage,

/JOB PURPOSE Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies. Essential Duties And Responsibilities Review clinical site regulatory documents t

Viatris Specialty LLC At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via Access Providing high quality trusted medicines regardless of geography or circumst

SHIFT Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a