Top 211986 Diagnostics Jobs

Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)
Entegee —Orange County, CA
- $45 - $50 an hour
- Full-time
- Hybrid work
- Mid-level
- 3 years
- Bachelor's degree
- Commuter assistance
- Disability insurance
Quick Apply
General Laboratory, Medical Technologist, Nights, Four 10s, Free Housing, $20,000 Sign-On Bonus
HealthCare Connections, Inc. —Nome, AK
- $99,000 - $128,000 a year
- 10 hour shift
- Hospital
- Mid-level
- Associate's degree
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Radiology Technologist
SSM Health —St. Louis, MO
- Part-time
- 18 years or older
- Surgery
- Ability to walk for extended periods
- Paid parental leave
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CV Sonographer II - North
Hendrick Health —Abilene, TX
- Full-time
- CPR Certification
- Management
- BLS Certification
Echo Sonographer
SSM Health —Bridgeton, MO
- From $35 an hour
- Part-time
- Hospital
- BLS Certification
- No experience needed
- Paid parental leave
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Sonographer - General and Vascular
TridentCare —Omaha, NE
- $40 - $50 an hour
- Full-time
- Background check
- Current TB test
- Nursing home
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Diagnostic Medical Physicist - Bachelor Level Physicist
Health Physics Northwest —Portland, OR
- $4,500 - $5,000 a month
- Full-time
- Background check
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- Health insurance
Quick Apply
Sonographer, Echocardiography Lead
Geisinger —Danville, PA
- Full-time
- 5 years
- Bachelor's degree
- ARRT Certification
- Wellness program
- Health savings account
Specialized Imaging Technologist - Perinatology / High-Risk Pregnancy
USC Perinatal Group —Los Angeles, CA
- $47 - $49 an hour
- Temporary
- Mid-level
- Clinic
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Quick Apply
Nuclear Medicine Technologist (CT/PET-CT)
Central Care Cancer Center —Great Bend, KS
- Mid-level
- Quality control
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- AD&D insurance
- Paid holidays
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Orthopedic Surgeon
Oasis Medical and Surgical Wellness Group —Union, NJ
- $1 - $2 a year
- Full-time
- Medicine
- Doctoral degree
- Surgery
- Health insurance
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Quick Apply
Certified Radiographer | Imaging ($15,000 sign-on bonus), Full-Time, 2nd shift with CT Experience
Memorial Health Ohio —Marysville, OH
- Full-time
- Hospital
- Mid-level
- Radiology
- Free parking
- Paid holidays
Quick Apply
MRI Technologist - PRN
Orthoindy —Lafayette, IN
- PRN
- Blood sampling
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- Mid-level
- 401(k) matching
Registered Vascular Technologist
American Vein & Vascular Institute —Highlands Ranch, CO
- $81,510 - $103,490 a year
- Full-time
- OSHA
- HIPAA
- Laboratory experience
- Relocation assistance
- Health insurance
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Registered Cardiac Echo Tech | PRN
Peterson Health —San Antonio, TX
- PRN
- CPR Certification
- Anatomy knowledge
- Hospital
- Health insurance
- Dental insurance
Quick Apply
Angio Tech - Cath Lab
Kettering Health —Dayton, OH
- Full-time
- Hospital
- BLS Certification
- Radiology
CT Technologist - CT Scan (Medical Imaging)
Glens Falls Hospital —Glens Falls, NY
- $33.08 - $49.62 an hour
- Hospital
- BLS Certification
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Radiologic Technologist > MRI/Xray
Ortho Montana —Billings, MT
- $25 - $35 an hour
- Full-time
- Background check
- BLS Certification
- Clinic experience
- Health insurance
- Dental insurance
Quick Apply
12d
Interventional Radiology Technologist/ Operating Room Technician
Guam Radiology Consultants —Tamuning, GU
- From $16 an hour
- Full-time
- CPR Certification
- Medication administration
- Surgery
- Health insurance
- Dental insurance
Quick Apply
Limited X-Ray Machine Operator (LXMO)
Sanford Health —Bemidji, MN
- Online Application
- Background check
- Pass drug screening
- Clinic
Quick Apply
4d

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Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)

Entegee -
Orange County, CA

Quick Apply

Job Details

Full-time | Contract
$45 - $50 an hour

Benefits

Commuter assistance
Disability insurance
Health insurance
Dental insurance
Vision insurance
Life insurance

Qualifications

Biology
Biochemistry
Technical documentation
Bachelor's degree
Manufacturing

Full Job Description

Hybrid position for a top Biotech company in Irvine, CA. 3 days a week onsite (core days are Tues/Thurs with 3rd onsite day a choice).

** If candidates don't have IVD industry experience, open to candidates with strong EU MDR submission experience! **

** Regulatory Affairs Specialist II with working knowledge of FDA, and CE marking requirements for IVD products. Company is currently transitioning from IVDD to IVDR (In-Vitro Diagnostic Regulation).

** The Regulatory Affairs Specialist is responsible for the preparation & revision of IVD technical files when needed, updating labeling to comply with IVDR requirements, and tracking RA Regional notifications.

How You'll Make An Impact:

Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity. Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the technical file. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work.
Support the IVDR labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule, the product fill dates, the associated product lot numbers and change requests numbers. As needed, update labeling specifications to meet the IVDR requirements.
Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document.
Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world.

What You Bring:

Requires a Bachelor's degree in biochemistry, biology, medical technology or related fields.
3-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry.
Knowledge of FDA, and CE marking requirements for IVD products is a plus.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

The Company will consider qualified applicants with arrest and conviction records.

#GRPA

Pay: $45.00 - $50.00 per hour

People with a criminal record are encouraged to apply

Work Location: Hybrid remote in Orange County, CA

Quick Apply

Refine Your Search

diagnostics jobs

Regulatory Affairs Specialist II (Need IVDD / IVDR and/or strong EU MDR experience)

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I want to receive the latest job alert for diagnostics

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