Top 16174 Coordinator Regulatory Programs 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
Director of Health Services (RN)
MBK Senior Living —Klamath Falls, OR
- $100,000 - $120,000 a year
- Full-time
- Nursing
- Current TB test
- LVN
- Wellness program
- Health insurance
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Child Psychiatrist
Interborough Developmental and Consultation Center —Brooklyn, NY
- $350,000 - $375,000 a year
- Full-time
- Bilingual
- Background check
- Medicine
- Profit sharing
- Health savings account
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Community Living Team Coordinator
Horizons Specialized Services —Steamboat Springs, CO
- $25.35 an hour
- Full-time
- Background check
- 18 years or older
- CPR Certification
- Health insurance
- Dental insurance
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Registered Nurse Educator
Iroquois Memorial Hospital & Resident Home —Watseka, IL
- $30.00 - $44.91 an hour
- Full-time
- Nursing
- RN License
- PALS Certification
- Health insurance
- Dental insurance
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MDS Nurse Coordinator
Frasier —Boulder, CO
- $33.30 - $42.45 an hour
- Full-time
- Background check
- Nursing
- Current TB test
- Commuter assistance
- Disability insurance
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Safety and Health Coordinator
Western Sugar Cooperative —Scottsbluff, NE
- $60,000 - $72,000 a year
- Full-time
- Background check
- Spanish
- Microsoft Outlook
- Relocation assistance
- Health insurance
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Surgical Preservation Coordinator- Scrub Tech, EMT, Surgical First Assist
Southern Legacy of Life —Little Rock, AR
- $29 - $36 an hour
- Overtime
- Anatomy knowledge
- Surgery
- Office
- Health insurance
- Dental insurance
Registered Nurse (RN)
Chariton Valley Association, Proud Partner of Center for Human Services —Hillsboro, MO
- $29.87 an hour
- Part-time
- Hybrid work
- Background check
- CPR Certification
- Nursing
- Retirement plan
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13d
Board Certified Behavior Analyst (BCBA)- Center Based
Kadiant —Riverbank, CA
- Up to $110,000 a year
- Full-time
- Mid-level
- Clinic
- Education
- Continuing education credits
- Paid holidays
Quick Apply
9d
Clinical Education Coordinator - Diagnostic Medical Sonography
Monroe University —Bronx, NY
- $80,000 - $90,000 a year
- Full-time
- Writing skills
- Clinic experience
- Mid-level
- Health savings account
- Health insurance
Quick Apply
Maintenance Coordinator (Position will be in one of our facilities ATL, San Antonio, or Elgin, IL)
Pedalpoint Evterra Recycling, LLC —San Antonio, TX
- $70,000 - $85,000 a year
- Full-time
- Ability to lift 50 pounds
- Mentoring
- In-person
- Health insurance
- Dental insurance
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Quality Improvement and Risk Management Coordinator
Brightwell Behavioral Health —Garden City, MI
- Full-time
- Nursing
- RN License
- Inpatient
- Health insurance
- Dental insurance
Quick Apply
RN
FLACRA —Newark, NY
- $36 - $37 an hour
- Per diem
- Management
- RN License
- Mid-level
Quick Apply
RN Staff Development Coordinator
Westside Village Nursing Center —Indianapolis, IN
- Full-time
- Anatomy knowledge
- RN License
- HIPAA
- Health insurance
- Dental insurance
Quick Apply
RN
FLACRA —Geneva, NY
- $36 - $37 an hour
- Part-time
- Management
- RN License
- Mid-level
Quick Apply
Environmental Health & Safety Coordinator
SmartSign, LLC —Oxford, NC
- $80,000 - $90,000 a year
- Full-time
- CPR Certification
- Up to 50% travel
- Mid-level
Quick Apply
Stability Coordinator I
Norwich Pharmaceuticals Inc —Norwich, NY
- $62,354 a year
- Full-time
- Computer literacy
- Organizational skills
- 1 year
- Wellness program
- Health savings account
Quick Apply
Nurse Coordinator (RN) - Rochester, NY
Hillside Children’s Center —Rochester, NY
- $75,000 - $90,000 a year
- Weekends as needed
- Background check
- Experience working with individuals with developmental disabilities
- Nursing
- 403(b) matching
- Health insurance
Quick Apply
10d
Staff Nurse CMH ER, .9 FT, 7pm - 7am
United Health Services —Norwich, NY
- $40.52 - $57.48 an hour
- Full-time
- Nursing
- RN License
- PALS Certification
- 403(b) matching
- Health insurance
Quick Apply

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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

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Refine Your Search

Coordinator Regulatory Programs jobs

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

Director of Health Services (RN)

Child Psychiatrist

Community Living Team Coordinator

Registered Nurse Educator

MDS Nurse Coordinator

Safety and Health Coordinator

Surgical Preservation Coordinator- Scrub Tech, EMT, Surgical First Assist

Registered Nurse (RN)

Board Certified Behavior Analyst (BCBA)- Center Based

Clinical Education Coordinator - Diagnostic Medical Sonography

Maintenance Coordinator (Position will be in one of our facilities ATL, San Antonio, or Elgin, IL)

Quality Improvement and Risk Management Coordinator

RN

RN Staff Development Coordinator

RN

Environmental Health & Safety Coordinator

Stability Coordinator I

Nurse Coordinator (RN) - Rochester, NY

Staff Nurse CMH ER, .9 FT, 7pm - 7am

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