Tri-Valley Career Center
Regulatory Affairs Specialist II - Temporary
Tri-Valley Career Center, Fort Worth, Texas, United States, 76102
Regulatory Affairs Specialist II - Temporary
Join to apply for the Regulatory Affairs Specialist II - Temporary role at Tri-Valley Career Center. 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 preparing revisions of technical files when needed, updating labeling to comply with IVDR requirements, tracking RA regional notifications, and other related activities. How You’ll Make An Impact
Support the IVDR project by revising the assigned technical files, ensuring each file is generated using the latest template and clearly presents the product, its characteristics, and expected performance. Include the latest versions of required technical reports, validations, test reports, and other documents listed in the file’s table of contents, and complete each file within a pre‑defined timeline. Attend multiple weekly meetings to address issues or questions regarding the technical files and keep the project manager informed on progress. Support the IVDR labeling conversion project, which requires cross prazits participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule, product fill dates, associated lot numbers and change‑request numbers. Support the tasks to remove CE Marking from selected products and track the work until final labeling reflects the desired changes, and address other miscellaneous activities such as updating the technical file tracking log and notifying RA regional notifications of labeling changes. What You Bring
Requires a bachelor’s degree in biochemistry natus biology, medical technology or related fields. 3‑5 years of experience in RA, 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. Strong communication, negotiation, and persuasion skills. 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 $40 to $47 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on factors such as geographic location, experience, knowledge, skills and abilities. 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, empowering you to build your career and drive impactful change. 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 personal and financial information from applicants. Beware of fake recruiters and job அவரது scams. Click here for more information on this scam and how to avoid it. Legal Entity: (USA_1000) Bio‑Rad Laboratories, Inc.
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Join to apply for the Regulatory Affairs Specialist II - Temporary role at Tri-Valley Career Center. 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 preparing revisions of technical files when needed, updating labeling to comply with IVDR requirements, tracking RA regional notifications, and other related activities. How You’ll Make An Impact
Support the IVDR project by revising the assigned technical files, ensuring each file is generated using the latest template and clearly presents the product, its characteristics, and expected performance. Include the latest versions of required technical reports, validations, test reports, and other documents listed in the file’s table of contents, and complete each file within a pre‑defined timeline. Attend multiple weekly meetings to address issues or questions regarding the technical files and keep the project manager informed on progress. Support the IVDR labeling conversion project, which requires cross prazits participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule, product fill dates, associated lot numbers and change‑request numbers. Support the tasks to remove CE Marking from selected products and track the work until final labeling reflects the desired changes, and address other miscellaneous activities such as updating the technical file tracking log and notifying RA regional notifications of labeling changes. What You Bring
Requires a bachelor’s degree in biochemistry natus biology, medical technology or related fields. 3‑5 years of experience in RA, 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. Strong communication, negotiation, and persuasion skills. 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 $40 to $47 at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on factors such as geographic location, experience, knowledge, skills and abilities. 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, empowering you to build your career and drive impactful change. 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 personal and financial information from applicants. Beware of fake recruiters and job அவரது scams. Click here for more information on this scam and how to avoid it. Legal Entity: (USA_1000) Bio‑Rad Laboratories, Inc.
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