Regulatory Affairs Specialist II - Temporary

Support the EU's In Vitro Diagnosic 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 activities.

How You’ll Make An Impact: 

• Support the IVDR labeling conversion and revisions of technical files for all Bio-Rad Irvine products that are due to convert from the IVD Directive requirements to the new IVD Regulation.
• Work cross-functionally in weekly meetings to ensure the labeling conversion follows the plan.
• Monitor the montly manufacturing schedule, track change requests, monitor manufacturing timelines and update the labeling tracking log to ensure accuracy of the associated product lot numbers, RA Regional notifications, RA Regional follow-ups and product restrictions, as required.
• Update previous revisions of IVDR Technical Files to the latest template and include all the necessary attachments.

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 rate for this position is $40 to $45 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. This position is eligible for a variable annual bonus, which is dependent upon achievement of your individual objectives and Company performance.

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 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

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