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

ZDZpR2R1bDVkbWJSWlJqSzZTdkJXWnk4dWc9PQ==
  • 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

Indiana Municipal Power Agency

Plant Systems Operator Job at Indiana Municipal Power Agency

 ...The Indiana Municipal Power Agency is seeking someone with mechanical skills and a strong work ethic to join our generation team at...  ...related auxiliary equipment. An understanding of the overall operation of a power plant or heavy industrial operation, its systems and... 

MH Energy

Class B Local Flatbed Delivery Driver Both CDL A and CDL B Openings Job Job at MH Energy

Class B Local Flatbed Delivery Driver Both CDL A and CDL B Openings JobTransport and unload various types of products using flatbed and driver helper. CDL A or B openings available, Hazmat a plus, but not required. Minimal experience needed, but must have city driving... 

Helen Ross McNabb Center

Psychiatric Nurse (RN or LPN) Job at Helen Ross McNabb Center

 ...Psychiatric Nurse (RN or LPN) We've been waitingfor someone like you! With a wide range ofavailable positions in East Tennessee,...  ...diagnosis disorders preferred. Computer experience in a health care setting required. Abilities /Skills: Must have excellent people... 

Confidential

Analytics Translator Lead (Fortune 100 Co Direct Hire) Job at Confidential

Job Summary: We are seeking an experienced Analytics Translator Lead to bridge the gap between data science teams and business stakeholders. In this hybrid role, you will work closely with cross-functional teams to translate complex analytical insights into clear, actionable...

Get It Recruit - Educational Services

Online Teacher - Remote | WFH Job at Get It Recruit - Educational Services

Are you passionate about helping students achieve their academic goals? We're looking for dedicated, experienced tutors and teachers with virtual tutoring experience to provide personalized 1:1 or group lessons to students across the country. This is a great opportunity...