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

Sr. Manager Government Affairs 49007BR USA California Mountain View/Sunnyvale, USA Oregon Hillsboro Job Description and Requirements Synopsys is seeking a proactive and agile leader to join its Federal Government Affairs office in Sunnyvale, CA as Sr. Manager, Government Affairs. This exciting and influential role will serve as Synopsys' strategist and engagement lead for

The Digital Compliance Manager is the lead position in a two person compliance team inside the Digital Strategy organization. The compliance lead will own the strategy for the compliance and risk management framework to ensure we are meeting applicable standards, laws & regulations. They will also oversee the work of a compliance team member who is responsible for managin

Pacific Life is investing in bright, agile and diverse talent to contribute to our mission of innovating our business and creating a superior customer experience. We're actively seeking a talented Senior Compliance Analyst to join our Distribution & Marketing Compliance team in Newport Beach, CA. This role can be on site or hybrid. As a Senior Compliance Analyst , you'll

Advantage Technical is seeking a Regulatory Affairs Specialist for our client in Irvine, CA. This position is Hybrid Monday Wednesday Friday on site and Tuesday Thursday remote. Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all our client's products currently CE Marked under the IVD Directive. Activities include preparation

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

Configure and administer Microsoft 365 applications, including SharePoint Online, OneDrive, and other collaboration tools to meet business needs. Design and implement SharePoint sites, libraries, lists, workflows, and permissions according to best practices and user requirements. Collaborate with stakeholders to understand business processes and translate them into effici

/JOB PURPOSE Responsible for creating, updating, and maintaining product information and labeling documentation for all relevant Exelixis products across our product portfolio. This position plays an important role in company wide initiatives around end to end labeling and provides dedicated support on Regulatory related activities and deliverables. This role requires an e

Through the operation of the Service Center, this position will develop and maintain a ministry of service and actively promote the structure and identity of The Salvation Army and its mission. The Coordinator will manage and supervise The Salvation Army's daily social service assistance programs within their community. They will work with their Field Representative to cr

Supports policy and regulatory activities that support the South Bay Large Load Program Management team's initiatives. Performs analysis in support of long term electric and natural gas strategies, electric energy forecasts, and transmission projects. Provides analytic support for advocacy on various policy issues. Develops methods and tools to value nonstandard products.

The Expert Strategic Analyst is responsible for owning and supporting several work streams and analysis projects within the Strategic Development's Partner of Choice initiative. This initiative is focused on how PG&E can better serve its customers, business partners, and communities through an improved customer experience, investment planning efforts, and research into ne

to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life changing treatments for patients with under addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis and uterine fibroids , as

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

Role summary Demonstrates full knowledge in assigned area and is an experienced sole contributor. Provides independent, rigorous analysis to inform portfolio construction decisions and highlight major risk positions within Capital's Fixed Income and multi asset portfolios. Proactively conducts advanced quantitative and qualitative analyses for portfolios. Represents risk m

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure wave