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Clinical Research Specialist II
1 week ago
Idaho State Job Bank Boise, United StatesClinical Research Specialist II - Laminar, Inc. at J&J Family of Companies in Boise, Idaho, United States Job Description Clinical Research Specialist II - Laminar, Inc W Description Laminar, part of the Johnson & Johnson family of Medical Device companies, is current recruiting ...
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Lead Regulatory Affairs
1 week ago
Idaho State Job Bank Boise, United StatesLead Regulatory Affairs & Compliance Strategist at Oracle in Boise, Idaho, United States Job Description Job Description We are seeking an experienced Regulatory Compliance Specialist to join our team The Medical Device team is responsible for assessing markets and products to en ...
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Plasma Center Nurse
2 weeks ago
BioLife Plasma Services Boise, ID, United StatesBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submi ...
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Plasma Center Nurse
2 weeks ago
BioLife Plasma Services Boise, ID, United StatesBy clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submi ...
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Plasma Center Nurse
5 days ago
BioLife Plasma Services Boise, ID, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
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Plasma Center Nurse
5 days ago
BioLife Plasma Services Boise, ID, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
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Health System Specialist
1 week ago
Department of Veterans Affairs Boise, United StatesSummary · The primary purpose of the position is to provide leadership, strategic direction, and oversight of the compliance activities for the medical facility and to ensure a standardized and effective approach to compliance using the compliance framework, Compliance and Integr ...
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Health System Specialist
1 week ago
Department of Veterans Affairs Boise, United StatesSummary · This position is located in the Office of the Director of a local health care system and reports to the Director, or a Chief Compliance Officer that reports to the Medical Center Director. · Learn more about this agency · Help · Overview · * Accepting applications · * O ...
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Security Onboarding Specialist
1 week ago
Idaho State Job Bank Boise, United StatesSecurity Onboarding Specialist (Remote) at GovCIO in Boise, Idaho, United States Job Description Overview GovCIO is currently hiring for a Part-Time (20hrs per week) Security Onboarding Specialist . This position will be a Fully Remote position. Responsibilities + Solicit onboard ...
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Department of Veterans Affairs Boise, United StatesSummary · The Audiology Cochlear Implant Clinical Specialist provides clinical service to veterans andother beneficiaries in VHA medical centers, clinics, domiciliaries, Community Living Centers,community care settings, and Community-Based Outpatient Clinics and by telehealth. · ...
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Department of Veterans Affairs Boise, United StatesSummary · The Audiology Telehealth Clinical Specialist provides clinical service to veterans and other beneficiaries in VHA medical centers, clinics, domiciliaries, Community Living Centers, community care settings, and Community-Based Outpatient Clinics and by telehealth. Audiol ...
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Peer Specialist
1 day ago
Idaho State Job Bank Boise, United StatesPeer Specialist at Veterans Affairs, Veterans Health Administration in Boise, Idaho, United States Job Description Summary This Peer Specialist position may only be filled with a Veteran that meets statutory requirements that are detailed in the qualifications section. Responsibi ...
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Lead Supply Technician
1 day ago
Idaho State Job Bank Boise, United StatesLead Supply Technician at Veterans Affairs, Veterans Health Administration in Boise, Idaho, United States Job Description Summary This position is for the Medical Supply Distribution (MSD) area of Logistics Service at the Boise VA Medical Center. Responsibilities Major duties inc ...
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Audiologist (Telehealth Clinical Specialist)
1 week ago
Veterans Affairs, Veterans Health Administration Boise, United StatesSummary The Audiology Telehealth Clinical Specialist provides clinical service to veterans and other beneficiaries in VHA medical centers, clinics, domiciliaries, Community Living Centers, community care settings, and Community-Based Outpatient Clinics and by telehealth. Audiolog ...
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IT Help Desk Technician
2 days ago
Idaho State Job Bank Boise, United StatesIT Help Desk Technician (Remote) at GovCIO in Boise, Idaho, United States Job Description Overview GovCIO is currently hiring a IT Helpdesk Support Technician. This position will be fully remote. Responsibilities + Coordinates communications with End Users as a Tier 1 Specialist ...
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IT Support Specialist I
1 day ago
Vacasa Boise, United States**IT Support Specialist I** · at Vacasa Boise. ID **Position Summary** · Vacasa is looking for a talented individual to join the IT team as an IT Support Specialist. Our success as a service company is dependent on excellent support agents who are able to assist the team with t ...
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Idaho State Job Bank Boise, United StatesDirector Quality Assurance Infectious Diseases/Vaccines at Merck in Boise, Idaho, United States Job Description Job Description Our Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compl ...
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Peer Specialist
1 day ago
VETERANS HEALTH ADMINISTRATION Boise, United StatesSummary · This Peer Specialist position may only be filled with a Veteran that meets statutory requirements that are detailed in the qualifications section. · This job is open to Career transition (CTAP, ICTAP, RPL) · Federal employees who meet the definition of a "surplus" or ...
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Purchasing Agent
1 day ago
VETERANS HEALTH ADMINISTRATION Boise, United StatesSummary · The position serves as a Purchasing Agent for the Optical Fabrication Lab (OFL) which is part of the Chief Logistics Service in a Veterans Integrated Network Service (VISN20). · This job is open to Career transition (CTAP, ICTAP, RPL) · Federal employees who meet the ...
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Regional Environmental Protection Specialist
14 hours ago
Gryphon Environmental LLC Boise, United StatesJob Description · Job DescriptionGryphon Environmental is seeking a full-time highly motivated individual for the position of Area Environmental Protection Specialist to provide environmental compliance support to U.S. Army Reserve (USAR) Centers primarily in Northern Utah, Idaho ...
Senior Regulatory Affairs Specialist - Boise, United States - Idaho State Job Bank
Description
Senior Regulatory Affairs Specialist at J&J Family of Companies in Boise, Idaho, United States Job Description Senior Regulatory Affairs Specialist W Description Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist.
Remote work options may be considered on a case-by-case basis and if approved by the Company Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.
Abiomed's 'Patients First' culture drives our skilled workforce and strong relationships with clinicians.Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.
Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices.
You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period.
Through your engagement in this role, you will help shape the life-saving field of heart recovery.The ideal candidate will:
Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices Be energized by joining a world-class company and regulatory team Enjoy teamwork and thrive as a member of dynamic cross-functional teams Build and maintain strong interpersonal relationships within and outside of the company Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results Adaptable and thrive in a dynamic work environment where variety is the routine.
Embrace change, continuous learning, and work skills improvement Key Responsibilities:Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA Provide ongoing support to project teams for regulatory issues and questions.
Find, interpret and apply regulations and guidance appropriately for situations Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance Provide support for To view full details and how to apply, please login or create a Job Seeker account
Senior Regulatory Affairs Specialist professionals in Boise
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Brandon Lyon
Human Resources/Talent Acquisition
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Ryan McDaniel
Project Manager
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Konni Hawkins
Customer Service Professional