Senior Regulatory Affairs Specialist Job at QuinTalent Inc, Irvine, CA

WDZ4dnAraEVaa1VWeXhkRDYrSlJlYVdiSUE9PQ==
  • QuinTalent Inc
  • Irvine, CA

Job Description

Regulatory Affairs Specialist II

12 months contract role at Irvine, CA

Pay is $50 to $55/hour

Work Mode - Hybrid - Core onsite days are Tue/Thurs with 3rd onsite day a choice and rest remote every week.

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact all Bio-Rad products currently CE Marked under the IVD Directive. Activities include preparation revision of technical files when needed, update labeling to comply with IVDR requirements, track RA Regional notifications, and other related activities.

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
  • 5-8 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the medical device industry.
  • Knowledge of FDA, and CE marking requirements for medical device/IVDs is a plus
  • Able to work independently and with others
  • Communication skills, including negotiation and persuasion.
  • Analytical, problem solving, computer, and critical thinking skills.
  • Thorough knowledge of policies, practices and procedures related to RA.

Job Tags

Contract work, Remote job,

Similar Jobs

JC Carpet & Upholstery Cleaning, INC.

carpet upholstery & tile/grout cleaning technician Job at JC Carpet & Upholstery Cleaning, INC.

 ...owned and operated business Role Description This is a part/full time role for the cleaning technician located in Vacaville, CA....  ...part of their daily responsibilities. Qualifications NO Experience in carpet cleaning, upholstery cleaning, and tile/grout... 

Engineering Firm

Civil Engineer Project Manager Job at Engineering Firm

 ...standards. Provide technical guidance and support to the construction team. Coordination & Communication: Liaise with clients, contractors, local authorities, and other stakeholders to ensure clear communication and collaboration throughout the project lifecycle.... 

The Stix Icehouse

High Volume Restaurant Manager Job at The Stix Icehouse

 ...that can learn our secret sauce and then lead in one of our future opportunities. The Manager candidate will possess the skillset to oversee a high-volume full-service restaurant and bar, including budgeting, ordering and scheduling. They should be high energy and have... 

Robinson Restoration

Commercial Electrician Job at Robinson Restoration

 ...Washington Will Consider Residential Journeyman with both states ```Duties:```- Install...  ...electrical systems and equipment in commercial and residential settings - Read and interpret...  ...:```- Journeyman/Journeywoman Electrician license or equivalent certification -... 

Net2Source Inc.

Administrative Assistant Job at Net2Source Inc.

 ...messages while interacting with high level business leaders and clients in a professional manner Coordinates domestic and international travel arrangements as required, including visa procurement, and processes expense reports or related invoices in a timely manner....