Regulatory Affairs Specialist- Temporary

Provide regulatory support for Bio-Rad products that will be transitioning from the IVDD to IVDR CE Marking. Collaborate with cross-functional groups (e.

g., Quality Assurance, Research & Development, Marketing) to collect and coordinate information and regulatory documentation to assemble IVDR compliant technical files.

Update IVDR Labeling Conversion Log, assure all documentation is prepared and processed timely to meet the manufacturing schedule.

Assist in the generation of Change Requests for product labeling according to Labeling conversion plan. Communicate and assist in the notification process to all International Regional RAs.

This may include sending the notification, logging regional responses and tracking RA Regional activities to completion.

Ensure product restrictions are implemented, as required. Perform other IVDR or regulatory related duties as required or assigned.,

How You'll Make An Impact :

• Able to work with minimal supervision
• Strong customer orientation and focus
• Able to work independently and with others

What You Bring :

• Education : Bachelor's Degree or equivalent in Biology, Chemistry, Medical Technology, or related field.
• Work Experience : 2 to 5 year's experience in Regulatory Affairs and / or experience in QA, R&D, Manufacturing within the IVD industry
• Effective communication skills, both written and oral
• Strong documentation and organizational skills
• Excellent computer applications skills including prior ERP experience and able to perform basic statistical analysis

Compensation : The estimated hourly range for this position is $43-$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.

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.

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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