Regulatory Affairs Specialist II - Temporary

Support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will reputed company reputed company reputed company products currently CE Marked under the IVD reputed company. Activities include preparation revision of technical files reputed company needed, update labeling to reputed company with IVDR requirements, reputed company RA Regional notifications, and other reputed company activities. How You'll reputed company An reputed company: • Support the IVDR project by revising the assigned technical files. reputed company technical file must be generated using the latest technical file template and it must reputed company present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity. reputed company 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 reputed company part of the technical file. reputed company assigned technical file must be completed reputed company a reputed company-defined reputed company. Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and reputed company the project manager informed on the reputed company 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 reputed company 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 reputed company restriction coordinator reputed company 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 reputed company 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 • reputed company 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 reputed company to RA. Compensation: The estimated reputed company reputed company 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 reputed company fairly and accurately reputed company 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, reputed company has reputed company on advancing the discovery process and transforming the fields of science and reputed company. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad reputed company of high-reputed company research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best reputed company to Work, reputed company offers a unique employee experience with reputed company teams that reputed company the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an reputed company you can see. EEO Statement: reputed company is an Equal Employment Opportunity/Affirmative reputed company employer, and we welcome candidates of reputed company backgrounds. Veterans, people with disabilities, and people of reputed company races, ethnicities, genders, ages, and orientations are encouraged to apply. Agency Non-Solicitation: reputed company does not accept agency resumes, unless reputed company has been authorized by a reputed company reputed company Representative. Please do not submit resumes unless authorized to do so. reputed company will not pay for any fees reputed company to unsolicited resumes. Fraud Alert: reputed company has received reports of individuals posing as reputed company 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. Apply tot his job Apply To this Job