Data Management Specialist – IVDR (EUDAMED) - Temporary
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Data Management Specialist – IVDR (EUDAMED) - Temporary
- 2025-37571
- California, United States
- Qualité et réglementation
- à distance
Bio-Rad is seeking a Data Management Specialist to support our Regulatory Affairs and Quality teams in the context of the EU In Vitro Diagnostic Regulation (IVDR). The successful candidate will be responsible for collecting, organizing, and entering regulatory data related to medical device registrations, and other associated attributes into our Product Data Management System. This role may also include performing system validation testing and drafting Standard Operating Procedures (SOPs) to ensure the sustainable maintenance and accuracy of these data over time
How You'll Make An Impact:
- Gather and consolidate regulatory data related to IVDR device registrations from internal and external sources.
- Enter and maintain data in the company’s product data management tool, ensuring completeness, accuracy, and compliance with internal standards.
- Develop and document Standard Operating Procedures (SOPs) and work instructions to support long-term data integrity and consistency.
- Collaborate with cross-functional teams (Regulatory Affairs, Quality, R&D, Supply Chain) to ensure data alignment and traceability.
- Support continuous improvement initiatives for data quality and process efficiency.
What You Bring:
- Bachelor’s degree (or equivalent) in Life Sciences, Quality Management, Regulatory Affairs, or related field.
- 1-2 years of experience in the medical devices or IVD industry is highly preferred.
- Strong attention to detail and commitment to accuracy and data integrity.
- Excellent organizational and analytical skills.
- Strong appreciation for the role of high-quality data in ensuring patient safety and regulatory compliance.
- Clear written and verbal communication skills in English.
- Proficiency in Microsoft Word, Excel.
Compensation: The estimated hourly range for this position is $ 30.00 to $40.00 per hour 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. 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 physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status 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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