Regulatory Affairs Intern

As the Regulatory Affairs Intern, you will support the Regulatory Affairs team by developing tools and templates that improve efficiency in the preparation of global regulatory submissions and documentation. This role will focus on automating the generation of regulatory registration dossiers, external reports, and regulatory declarations by leveraging structured data sources and internal databases.

Location: This position must be based in Irvine, California and requires the employee to be located within commuting distance of the office.

How You'll Make An Impact:

The intern will help streamline regulatory processes, reduce manual data entry, and improve consistency across submission documents.

What You Bring:

• Currently pursuing a Bachelor's or Master's degree at an accredited University, in Regulatory Affairs, Life Sciences, Biomedical Engineering, Computer Science, Data Science, or a related field. Eligible candidates must be rising juniors, seniorsk, or graduate students who intend to return to their academic program the following academic year.
• A minimum cumulative GPA of 3.0 on a 4.0 scare is required.
• Prior internship, academic, or project experience in Regulatory Affairs, Quality, document management, data automation, or regulated industries preferred but not required.
• Exposure to medical device or in vitro diagnostic (IVD) regulatory environments is a plus.
• Familiarity with global regulatory concepts or regulatory submissions is desirable.
• Proficiency in Python for Natural Language Processing (NLP) applications.
• Experience with SQL for querying and managing structured data.
• Strong working knowledge of Microsoft Office (Word, Excel, PowerPoint).
• Comfortable working with: Word documents and structured templates; Excel trackers and data tables; Controlled document management systems or SharePoint.
• Strong attention to detail and consistency when working with regulatory documentation.
• Ability to follow established templates, procedures, and instructions in a controlled environment.
• Strong problem-solving, decision-making, and time management skills.
• Ability to manage multiple tasks and meet deadlines.
• Excellent written communication and documentation skills.
• Strong organizational skills and ability to maintain document accuracy and traceability.

Total Rewards Package: At Bio-Rad, we're empowered by our purpose and recognize that our employees are as well. That's why we offer a competitive and comprehensive Total Rewards Program that provides value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Bio-Rad's robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee's work and life cycle.

Benefits: We're proud to offer a variety of options, including competitive medical plans for you and your family, free HSA funds, a new fertility offering with stipend, group life and disability, paid parental leave, 401k plus profit sharing, an employee stock purchase program, a new upgraded and streamlined mental health platform, extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges and support, paid time off, Employee Resource Groups (ERG's), and more!

Compensation: The estimated hourly rate for this position is $25.00 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. 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. #LI-JS1