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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
Posted 8 days ago
Duties WHAT IS THE LARGE BUSINESS AND INTERNATIONAL (LBI) DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Large Business and International Director Northeastern Compliance Practice Area (NECPA) The following are the duties of this position at the full working level. If this vacancy includes more than
Posted 25 days ago
OF POSITION Independently authors, compiles, reviews, and schedules high quality regulatory submissions in adherence with standards that are fully compliant with FDA and ICH requirements within company timelines. Plans, coordinates and writes, clear, concise and accurate, responses to inquiries from FDA resulting from their review of the submissions. Submissions will inclu
Posted 26 days ago
A collective energy and ambition. A place where you can make a real difference. We're a company that genuinely cares about our people, our products, our consumers and the environment. Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and owner
Posted 16 days ago
Manage Regulatory Affairs, Advertising & Promotion and Compliance Group Manage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motivate line reports to achieve shared and individual goals. Regulatory Leadership of Advertising and Promotional Materials Serve as subject matter
Posted 29 days ago
Job description Our purpose Opening up a world of opportunity explains why we exist. Here at HSBC we use our unique expertise, capabilities, breadth and perspectives to open up new kinds of opportunity for our more than 40 million customers. We're bringing together the people, ideas and capital that nurture progress and growth, helping to create a better world for our cus
Posted 24 days ago
Internal Revenue Service
- Anchorage, AK / Birmingham, AL / Phoenix, AZ / 74 more...
Duties WHAT IS THE APPEALS DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas Independent Office of Appeals Specialized Exam Programs & Referrals/Area 10/Team 2 The following are the duties of this position at the full working level. Conducts Appeals conferences for the settlement of the largest and most
Posted 19 days ago
Prepares /oversees the preparation of various regulatory submissions including Pre Submissions, 510(k) submissions, CLIA Waiver Applications, Dual 510(k)/Waiver by Applications, technical files, and license applications. Monitors new and changing regulations and guidance and disseminates information to stakeholders. Identifies regulatory trends and conducts key regulatory
Posted 29 days ago
Reviews and interprets regulations/guidance documents to develop regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, IND & CMC strategies, submission requirements, timing and risks. Interact with US FDA and acts as a liason with Corporate International RA and/or country RA to define submission content, expedite pend
Posted 30 days ago
Develop solutions to improve processes for global regulatory submissions. Identify, implement, support validation and manage software tools for organizing regulatory files, registration tracking and documentation for submissions Manage Regulatory tools/database and new enhancements. Interact with global regulatory leaders and peers to share and manage department metrics a
Posted 30 days ago
The Interoperability Regulations and Standards, Director will work with key external stakeholders to summarize lab related industry standards and regulations and translate any business impact to internal stakeholders. When impactful, this role will be responsible to coordinate internal stakeholders to further assess any impact and help establish solutions. The role will c
Posted 1 day ago
Drafting and editing Citi's responses to the Regulatory Consent Orders and related transformation efforts across businesses, functions, and regions, as needed, acting in close collaboration with the Transformation Office, the Transformation Central Legal Team and the CAO Office, among others Strategic thought leadership around effective representations of Citi's work to i
Posted 2 days ago
DOT is seeking a dynamic City Planner to implement the future of outdoor dining in New York City as a member of the Open Restaurants team. NYC launched the groundbreaking Open Restaurant Program during the height of the COVID 19 emergency to expand outdoor dining options and help restaurants rebound in difficult economic times. The City is now working to turn the emergenc
Posted 11 days ago
DOT is seeking a dynamic City Planner to implement the future of outdoor dining in New York City as a member of the Open Restaurants team. NYC launched the groundbreaking Open Restaurant Program during the height of the COVID 19 emergency to expand outdoor dining options and help restaurants rebound in difficult economic times. The City is now working to turn the emergenc
Posted 21 days ago
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
Posted 25 days ago
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