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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 28 days ago
What will you do? PROVIDE STRATEGIC REGULATORY GUIDANCE TO MANAGEMENT AND INTER DISCIPLINARY PROJECT TEAMS Provide guidance to inter disciplinary project teams on regulatory requirements on projects at Phase 1 to 4 of drug development/life cycle. Represent independently and proactively regulatory requirements and RA departmental positions to core/projects teams. Generate
Posted 1 month 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 29 days ago
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
Posted 15 days ago
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
Posted 16 days ago
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
Posted 3 days ago
Sr. Counsel, Regulatory Job Category Legal & Government Affairs Location Palo Alto, California Req. ID 220856 Job Type Full time Tesla participates in the E Verify Program What to Expect Tesla is seeking an experienced counsel to work on vehicle safety, compliance and homologation, government reporting, and supporting service and engineering. You will provide strategic po
Posted 3 days ago
Job Posting Associate Director, Office of Program Support Department of Corrections & Rehabilitation JC 423304 Associate Director, Office of Program Support C. E. A. $11,435.00 $13,623.00 per Month Final Filing Date 4/22/2024 Job Description and Duties The California Department of Corrections and Rehabilitation (CDCR) seeks a dynamic Associate Director (AD), Office of Pro
Posted 8 days ago
Job Posting Chief, Field Operations Department of Corrections & Rehabilitation JC 422825 Chief, Field Operations C. E. A. $11,716.00 $15,049.00 per Month Final Filing Date 4/2/2024 Job Description and Duties The California Department of Corrections and Rehabilitation (CDCR) is seeking their next dynamic executive leader who will provide direction and oversight over CDCR's
Posted 10 days ago
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
Posted 17 days ago
Providence
- Portland, OR / Los Angeles, CA / Beaverton, OR / 1 more...
Providence Health Plan caregivers are not simply valued they're invaluable. Join our team and thrive in our culture of patient focused, whole person care built on understanding, commitment, and mutual respect. Your voice matters here, because we know that to inspire and retain the best people, we must empower them. Providence Health Plan is calling a Director Regulatory A
Posted 14 days ago
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
Posted 1 month ago
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
Posted 24 days ago
The Department of Surgery is seeking to hire a full time Clinical Research Regulatory Coordinator to be responsible for regulatory coordination of clinical research studies within assigned units, departments or divisions. In this role you will complete the following duties Perform detailed review of clinical research protocols and utilizes that information to prepare Mana
Posted 1 month ago
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