Tri-Valley Career Center
Regulatory Affairs Specialist II - Temporary
Tri-Valley Career Center, Irvine, California, United States, 92713
Regulatory Affairs Specialist II - Temporary
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 and revision of technical files, update labeling to comply with IVDR requirements, track regional notifications, and other related activities.
Key Responsibilities
Revise assigned technical files using the latest template, ensuring the product, its characteristics, and expected performance are clearly presented, including required technical reports, validations, and test reports. Complete within defined timelines and attend weekly meetings to address issues and keep the project manager informed.
Support the IVDR labeling conversion project, participating in cross‑functional teams, updating the labeling conversion tracking log based on manufacturing schedules, fill dates, lot numbers, and change requests, and updating labeling specifications as needed to meet IVDR requirements.
Assist with un‑CE marking selected products and track work until final labeling reflects desired changes according to the labeling specification document.
Maintain technical file tracking logs, notify and track regional notifications of labeling changes, and communicate with the RA SAP restriction coordinator when specific product lots must be restricted to prevent distribution to certain regions.
Qualifications
Bachelor's degree in biochemistry, biology, medical technology or related fields.
3‑5 years of experience in Regulatory Affairs, QA, R&D, Manufacturing or Project Management in the IVD industry.
Knowledge of FDA and CE marking requirements for IVD products is a plus.
Ability to work independently and collaboratively.
Strong communication skills, including negotiation and persuasion.
Analytical, problem‑solving, computer, and critical thinking skills.
Comprehensive knowledge of policies, practices and procedures related to regulatory affairs.
Compensation The estimated hourly range for this position is $45–$50. Actual compensation will be provided in writing at the time of offer and may vary based on factors such as geographic location, experience, and skills. This is a temporary associate position managed through an approved agency provider.
About Bio‑Rad 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.
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 Restrictions 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.
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Key Responsibilities
Revise assigned technical files using the latest template, ensuring the product, its characteristics, and expected performance are clearly presented, including required technical reports, validations, and test reports. Complete within defined timelines and attend weekly meetings to address issues and keep the project manager informed.
Support the IVDR labeling conversion project, participating in cross‑functional teams, updating the labeling conversion tracking log based on manufacturing schedules, fill dates, lot numbers, and change requests, and updating labeling specifications as needed to meet IVDR requirements.
Assist with un‑CE marking selected products and track work until final labeling reflects desired changes according to the labeling specification document.
Maintain technical file tracking logs, notify and track regional notifications of labeling changes, and communicate with the RA SAP restriction coordinator when specific product lots must be restricted to prevent distribution to certain regions.
Qualifications
Bachelor's degree in biochemistry, biology, medical technology or related fields.
3‑5 years of experience in Regulatory Affairs, QA, R&D, Manufacturing or Project Management in the IVD industry.
Knowledge of FDA and CE marking requirements for IVD products is a plus.
Ability to work independently and collaboratively.
Strong communication skills, including negotiation and persuasion.
Analytical, problem‑solving, computer, and critical thinking skills.
Comprehensive knowledge of policies, practices and procedures related to regulatory affairs.
Compensation The estimated hourly range for this position is $45–$50. Actual compensation will be provided in writing at the time of offer and may vary based on factors such as geographic location, experience, and skills. This is a temporary associate position managed through an approved agency provider.
About Bio‑Rad 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.
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 Restrictions 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.
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