Top 231862 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
Quick Apply
Echo Sonographer
SSM Health —Bridgeton, MO
- From $35 an hour
- Part-time
- Hospital
- BLS Certification
- No experience needed
- Paid parental leave
- Health insurance
CV Sonographer II - North
Hendrick Health —Abilene, TX
- Full-time
- CPR Certification
- Management
- BLS Certification
Radiology Technologist
SSM Health —St. Louis, MO
- Part-time
- 18 years or older
- Surgery
- Ability to walk for extended periods
- Paid parental leave
- Health insurance
Echo Technologist
Heritage Imaging —Chippewa Falls, WI
- Full-time
- Hospital
- Clinic experience
- Mid-level
- Mileage reimbursement
- Health savings account
Quick Apply
13d
Registered Cardiac Echo Tech | PRN
Peterson Health —San Antonio, TX
- PRN
- CPR Certification
- Anatomy knowledge
- Hospital
- Health insurance
- Dental insurance
Quick Apply
Computed Tomography CT Radiology Technologist
SSM Health —Midwest City, OK
- Part-time
- BLS Certification
- No experience needed
- Operating room
- Paid parental leave
- Health insurance
Nuclear Medicine Technologist (CT/PET-CT)
Central Care Cancer Center —Great Bend, KS
- Mid-level
- Quality control
- Radiology
- AD&D insurance
- Paid holidays
Quick Apply
Sonographer - General and Vascular
TridentCare —Omaha, NE
- $40 - $50 an hour
- Full-time
- Background check
- Current TB test
- Nursing home
- Paid holidays
- Disability insurance
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 (Outpatient)
Atrium Health Wake Forest Baptist Outpatient Imaging - Winston Salem, Kernersville and Greensboro, NC —Greensboro, NC
- Full-time
- Customer service
- Mid-level
- Clinic
- Health savings account
- Paid holidays
Quick Apply
Computed Tomography CT Radiology Technologist
SSM Health —Midwest City, OK
- $25,000 a year
- Full-time
- BLS Certification
- No experience needed
- Operating room
- Paid parental leave
- Health insurance
Specialized Imaging Technologist - Perinatology / High-Risk Pregnancy
USC Perinatal Group —Los Angeles, CA
- $47 - $49 an hour
- Temporary
- Mid-level
- Clinic
- Ob/Gyn
Quick Apply
Hazardous Materials Deliver Contractor (CDL with Hazmat Endorsement)
Associated Couriers LLC (ICP) —St. Louis, MO
- Part-time
- CDL B
- Clean driving record
- Hazmat Endorsement
Quick Apply
Computed Tomography CT Radiology Technologist
SSM Health —Midwest City, OK
- Full-time
- BLS Certification
- No experience needed
- Operating room
- Paid parental leave
- Health insurance
MRI Technologist - PRN
Orthoindy —Lafayette, IN
- PRN
- Blood sampling
- Vital signs
- Mid-level
- 401(k) matching
Mammography Tech 2, Diagnostic Ctr - Brickell, $25000 Bonus,FT
Baptist Health South Florida —Miami, FL
- $35.11 - $45.64 an hour
- Full-time
- Hospital
- BLS Certification
- Mid-level
- Wellness program
- Health insurance
CT Tech - $7,500 Sign-On Bonus - We Want YOU on Our Team!
Iredell Memorial Hospital Incorporated —Statesville, NC
- Full-time
- Ability to lift 50 pounds
- Pediatrics
- Entry level
Quick Apply
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
Quick Apply

I want to receive the latest job alert for diagnostics

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

diagnostics jobs near

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)

General Laboratory, Medical Technologist, Nights, Four 10s, Free Housing, $20,000 Sign-On Bonus

Echo Sonographer

CV Sonographer II - North

Radiology Technologist

Echo Technologist

Registered Cardiac Echo Tech | PRN

Computed Tomography CT Radiology Technologist

Nuclear Medicine Technologist (CT/PET-CT)

Sonographer - General and Vascular

Diagnostic Medical Physicist - Bachelor Level Physicist

Sonographer (Outpatient)

Computed Tomography CT Radiology Technologist

Specialized Imaging Technologist - Perinatology / High-Risk Pregnancy

Hazardous Materials Deliver Contractor (CDL with Hazmat Endorsement)

Computed Tomography CT Radiology Technologist

MRI Technologist - PRN

Mammography Tech 2, Diagnostic Ctr - Brickell, $25000 Bonus,FT

CT Tech - $7,500 Sign-On Bonus - We Want YOU on Our Team!

Registered Vascular Technologist

I want to receive the latest job alert for diagnostics

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected