RA Spec I - Temporary

Support Bio-Rad's commitment to quality and compliance by coordinating the Domestic and Intl Registration Requests as a Regulatory Specialist. As part of Bio-Rad's Seattle Opeartions RA team, you’ll apply your strong leadership skills and knowledge of regulatory requirements to ensure that we register and distribute products that are in compliance to local and international regulations and applicable standards, escalate issues as necessary, complete necessary documentation and optimize our processes and procedures. You’ll also work closely with SO RA team and cross functional teams to ensure all the product and facility registration activities are complete and change assessments are documented as needed.

How You'll Make An Impact:

• Help to create and foster a quality environment and mindset throughout the business by coordinating the Domestic and International Regulatory Registrations, Regulatory Change Assessment including weekly meetings, workflows and documentation, and escalations
• Document management: Maintains and stores records in the file room including but not limited to current quality certificates, MOUs, Design History Files, and other records as assigned.
• Maintain the consistency of high quality standards across Bio-Rad by aligning local and regional procedures with our global processes and expectations
• Drive change and transform the way we tackle challenge with support for additional quality and compliance activities, including audits and inspections

What You Bring:

• Bachelor's degree, or equivalent, in Biology, Chemistry, Engineering, or related field.
• Minimum of 2 years experience in Regulatory Affairs, or equivalent combination of education and experience relating to IVD/Medical Devices/Biologics, with responsibility in coordination of international regulatory registrations.
• Technical Writing Skills and experience with labeling process is preferred.
• Proficiency in interpretation and application of US and outside US regulatory requirements for IVD/Medical Devices/Biologics.
• Ability to manage multiple complex projects with defined timelines. Excellent written and verbal communication skills required for negotiation with internal and external parties.

Compensation: The estimated hourly rate for this position is $40 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

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