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

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

Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED DIVISION? A description of the business units can be found at Vacancies will be filled in the following specialty areas SBSE Small Business/Self Employed, SB/SE Deputy Commissioner Exam, Specialty Examination, Estate & Gift /Excise Tax Exam The following are the duties of this position at the full working level. If this vaca

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

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

MLTC Dir of Contracts/Compliance Job Locations US NY Bronx ID 2024 4997 Category Regulatory Compliance Position Type Regular Full Time Overview RiverSpring Health Plans serves over 16,000 frail individuals and help them live in their homes and independently for as long as possible. Join our compassionate and dedicated team and make a difference in the lives of our members

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

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

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

In order to be considered for this position candidate must be serving permanently in the City Planner title, or be reachable on the civil service list, or eligible under the 55a program. The Division of Transportation Planning & Management is responsible for the safe, efficient, and environmentally responsible movement of people and goods on the City's streets, supporting

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