Top 71069 SAP Jobs | SimplyHired

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
Senior Implementation Specialist-DUE 7/9 by 3 pm Central
ABBTECH Professional Resources, Inc. —Ashburn, VA
- $59 - $74 an hour
- Temporary
- Mid-level
- Travel
- US work authorization
- AD&D insurance
- Paid holidays
Quick Apply
10d
SAP Fieldglass System Coordinator
INSPYR Solutions —Miami, FL
- $25 - $27 an hour
- Contract
- Remote
- Microsoft Excel
- Research
- Mid-level
- Health insurance
- 401(k)
Quick Apply
S4 SAP FICO Consultant
UST —Pennsylvania
- $109,000 - $164,000 a year
- Remote
- Mid-level
- Fair chance
- Paid jury duty
- Health savings account
Quick Apply
8d
SAP BRIM S/4HANA Functional Consultant - FICA _Contract Role
INFO ORIGIN INC —Harrisburg, PA
- $100 - $115 an hour
- Contract
- Remote
- Microsoft Excel
- DevOps
- Mid-level
Quick Apply
Senior SAP Application Consultant, FICO
NTT Ltd —Cincinnati, OH
- $139,027 - $191,271 a year
- Background check
- Senior level
- Paid holidays
- Health insurance
Acquisition Program Analyst / Systems Engineer
A² Systems Engineering —El Segundo, CA
- $170,000 - $200,000 a year
- Full-time
- Engineering
- In-person
- Senior level
- Paid jury duty
- AD&D insurance
Sr. Tax Analyst
Voith Group —Appleton, WI
- CPA
- Customer service
- Research
- Tuition reimbursement
- 401(k) matching
Quick Apply
Maintenance Manager
TreeHouse Foods —Cambridge, MD
- $97,500 - $146,300 a year
- Full-time
- Engineering
- Analysis skills
- Supervising experience
- Paid training
- Tuition reimbursement
Maintenance Manager
American Air Filter International —Columbia, MO
- Microsoft Excel
- Microsoft Outlook
- Ability to walk for extended periods
Quick Apply
Senior Procurement Mechanical Engineer
DEDIENNE AEROSPACE, LLC —Miami, FL
- $85,000 a year
- Full-time
- Engineering
- Master's degree
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
Maintenance Manager
TreeHouse Foods —Tonawanda, NY
- $97,500 - $146,300 a year
- Full-time
- Engineering
- Analysis skills
- Supervising experience
- Paid training
- Tuition reimbursement
North America Regional Freight Audit and Cost Control Lead - Global Manufacturer
AkzoNobel —Nashville, TN
- $105,000 - $115,000 a year
- 5 years
- Bachelor of Science
- Office
- Paid parental leave
- AD&D insurance
Quick Apply
Production Planner
Chinook Medical Gear, Inc. —Tulsa, OK
- $55,000 - $65,000 a year
- Full-time
- Background check
- Oracle
- ERP systems
- Health insurance
- Dental insurance
Quick Apply
SAP Project Manager
Natuvion —Miami, FL
- $90,000 - $140,000 a year
- Full-time
- Hybrid work
- Spanish
- PMP
- Office
- Health insurance
- Dental insurance
Quick Apply
Accountant (Hybrid - Kaukauna, WI)
Ahlstrom —Kaukauna, WI
- Microsoft Excel
- Mid-level
- Analysis skills
Quick Apply
Process Planner/ purchasing/ order entry (1 year min machining experience required)
North Country Engineering —Derby Center, VT
- $25.00 - $31.50 an hour
- Full-time
- Inventory management
- ERP systems
- Mid-level
- Health insurance
- Paid time off
Quick Apply
1d
Director of Finance
Korber Pharma —Fargo, ND
- Full-time
- Management
- CPA
- Bachelor of Science
- Health insurance
- Dental insurance
Sentinel ICBM Launch Execution Engineer
BAE Systems Inc. —Hill AFB, UT
- $120,874 - $205,486 a year
- Full-time
- Computer science
- Microsoft Excel
- Computer Science
- Health savings account
- Paid holidays
Project Engineer
Archroma U.S., Inc. —Aiken, SC
- Full-time
- Mid-level
- Fair chance
- In-person
- Health savings account
- Health insurance
Quick Apply
1d

I want to receive the latest job alert for SAP

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

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

SAP jobs

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

Senior Implementation Specialist-DUE 7/9 by 3 pm Central

SAP Fieldglass System Coordinator

S4 SAP FICO Consultant

SAP BRIM S/4HANA Functional Consultant - FICA _Contract Role

Senior SAP Application Consultant, FICO

Acquisition Program Analyst / Systems Engineer

Sr. Tax Analyst

Maintenance Manager

Maintenance Manager

Senior Procurement Mechanical Engineer

Maintenance Manager

North America Regional Freight Audit and Cost Control Lead - Global Manufacturer

Production Planner

SAP Project Manager

Accountant (Hybrid - Kaukauna, WI)

Process Planner/ purchasing/ order entry (1 year min machining experience required)

Director of Finance

Sentinel ICBM Launch Execution Engineer

Project Engineer

I want to receive the latest job alert for SAP

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected