Regulatory Affairs Specialist

1 week ago

Irvine, United States Bio-Rad Laboratories Full time

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

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 desirerd 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
  • 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.

Compensation: The estimated hourly range for this position is $45 to $50 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors. As a temporary associate, your employment will be managed directly through our approved agency provider.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

Fraud Alert: Bio-Rad has received reports of individuals posing as Bio-Rad recruiters to obtain information, including personal and financial, from applicants. Beware of these fake ‘recruiters‘ and job scams. Click here for more information on this scam and how to avoid it.

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