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

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

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

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

Senior Government Biller Collector Facility Prime Healthcare Management Inc Location US CA Ontario ID 2024 157761 Category Admin Position Type Full Time Shift Days Job Type Non Exempt Overview Prime Healthcare is an award winning health system headquartered in Ontario, California. Prime Healthcare operates 45 hospitals and has more than 300 outpatient locations in 14 stat

What we are looking for Desire to learn Regulatory Affairs CMC and global submission strategy Strong organizational skills with attention to detail Proficient time management skills and ability prioritize workload Ability to work both independently and as a member of a team Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project Experie

Job Posting Associate Director, Behavioral Health Reintegration Department of Corrections & Rehabilitation JC 427655 Associate Director, Behavioral Health Reintegration C. E. A. $9,755.00 $11,807.00 per Month Final Filing Date 5/4/2024 Job Description and Duties The California Department of Corrections and Rehabilitation (CDCR) is seeking their next professional executive

Job Posting Equity Officer (CEA, Level A) Department of Corrections & Rehabilitation JC 427547 Equity Officer (CEA, Level A) C. E. A. $9,755.00 $11,807.00 per Month Final Filing Date 5/4/2024 Job Description and Duties The California Department of Corrections and Rehabilitation (CDCR) and California Correctional Health Care Services (CCHCS) is seeking a diversity, equity,

Job Posting Associate Director, Administrative Support Department of Corrections & Rehabilitation JC 427647 Associate Director, Administrative Support C. E. A. $9,755.00 $11,807.00 per Month Final Filing Date 5/6/2024 Job Description and Duties This position is pending CalHR approval. The California Department of Corrections and Rehabilitation (CDCR) is seeking their next

The purpose of this position is to develop and maintain a ministry of service and actively promote the structure and identity of The Salvation Army and its mission through the operation of the Service Center. The Coordinator will manage and supervise The Salvation Army's social services programs providing assistance to clients within their community. They will work with t

Community Ministry Represent The Salvation Army within the faith based community. Provide assistance within the guidelines of The Salvation Army, including referrals to other faith based resources as needed. General Office Duties Produce and process office correspondence, including letters, emails, and mass mailings. Maintain and inventory all Salvation Army equipment and

The Department of Urology is seeking to hire a full time Clinical Trails Regulatory Coordinator to be responsible for regulatory coordination of clinical research studies within assigned units at the Institute of Urologic Oncology. Main responsibilities include Performing detailed review of clinical research protocols and utilizing that information to prepare, manage and