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

SFhJYWxGZUd6MU1SMVZXcnFrNHlOSUpCWHc9PQ==
  • 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,

Similar Jobs

Sherwin-Williams

Delivery Driver Job at Sherwin-Williams

 ...from Sherwin-Williams stores using box and flat-bed trucks. Drivers ensure deliveries are complete, packed correctly, and safely delivered to...  ...the store vehicle and alert the supervisor to repair and servicing needs Provide excellent customer service, answer questions... 

Marksmen

Executive Assistant Job at Marksmen

Is this the right job for you? If you find meaning and purpose in collaborating with and supporting others at work, maintaining a friendly work environment, and thrive in setting up an executive for success, then we cant wait to have you join us! About you We are...

Ultimate Staffing

Document Control Specialist Job at Ultimate Staffing

 ...Document Control Specialist Santa Clarita, California FULLY ONSITE - remote work NOT offered. ONLY local applicants will be considered....  ...to Production Process Quality Assurance documentation review Maintain Quality Assurance hard copy and electronic files for... 

Botanic

Garden Center Sales Associate Job at Botanic

 ...Garden Center Sales Associate: Job Description: We are seeking people who have a passion for plants and want to work with a team of like-minded individuals. As a sales associate in our garden center, you are responsible for assisting customers with their needs and... 

The Morning Star Trucking

Local Class A Truck Driver Training-Class A Truck Drivers Job at The Morning Star Trucking

Local Class A Truck Driver Training-Class A Truck DriversThe Morning Star Trucking Company provides transportation services for bulk tomato...  ...d like. Create a Driver's Account.Person to Contact about this CDL Job: Toni BurgessThe Morning Star Trucking Phone Number: 530473...