Regulatory Affairs Specialist Job at QuinTalent Inc, Hercules, CA

SEhFYWwxeU55bElVMVZTdnBrczZNSVJIVkE9PQ==
  • QuinTalent Inc
  • Hercules, CA

Job Description

RA Specialist I - Jackie

Hybrid after 30 days Mondays and Tuesdays on site, the third day candidate’s choice. 8:00 to 4:30 however we are flexible. Experience in IVD medical device industry. is required

1 yearn - $40/hour pay

Provide regulatory support for IVD products with multiple product groups with clinical diagnostics. Assembles low to medium complexity regulatory submissions to support world wide product registration. IVDR Technical file maintenance and monitoring of change requests. Process improvements for SOPs related to full transition to IVDR. Basic analytical, communication, problem solving, and critical thinking skills to meet daily job responsibilities. Interface daily with desktop publisher, technical writers and regulatory specialists. Work collaboratively with Marketing, R & D, QA, Planning and Manufacturing teams.

How You'll Make An Impact:

  • Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
  • Ability to communicate effectively with employees across multiple departments
  • Highly organized and detail-oriented. Good time management.
  • Technical aptitude for understanding IVD product features
  • Understanding of databases and electronic systems.

What You Bring:

  • Education: BS in Biology or other scientific field
  • Work Experience:3-5 year’s experience in IVD regulatory affairs .
  • Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)
  • Laboratory research experience in an IVD medical device regulated environment is strongly preferred.
  • Understanding of scientific reports, risk management, Quality Systems

Job Tags

Work experience placement, Flexible hours,

Similar Jobs

Softworld, a Kelly Company

Data Analyst Job at Softworld, a Kelly Company

 ...Job Title : SAP Data Analyst (Contract 6-12 months+) Job Location : Hybrid, Redmond, WA 98052 Onsite Requirements: data cleanup configurator tool SAP Job Description : This contractor position is to assist with data cleanup, validation... 

EBizCharge

Creative Content Writer Job at EBizCharge

Headquartered in Irvine, California, EBizCharge specializes in developing integrated payment solutions that facilitate electronic payment processing within ERP, CRM, Mobile, and eCommerce applications. Our applications are PCI compliant and fully integrated with major ...

Entegee

Project Manager Job at Entegee

 ...precision machining and fabrication facility is seeking a hands-on Project Manager with a background in mechanical engineering and CAD...  ...multitask in a hands-on, fast-paced environment Preferred Experience: ~35 years in a machine shop or manufacturing project... 

Aldinger Co.

Delivery Driver - Part Time (Tescom, An Aldinger Company) Job at Aldinger Co.

 ...We are seeking a reliable and dedicatedPart-Time Delivery Driverto join our team atTescom, an Aldinger Company. As a Delivery Driver, you will be responsible for transporting customer equipment safely and efficiently, while delivering top-notch service to ensure... 

Ellaway Blues Consulting

Night shift: Field Service Technician Job at Ellaway Blues Consulting

Position Summary: We are seeking a qualified NETA Field Technician to join our growing team. This role involves performing testing, inspection, maintenance, and repair of electrical power systems, primarily in the field. The ideal candidate will be certified by the ...