Fremont, California, USA
14 days ago
Regulatory Affairs Quality Intern

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with shown competencies and strong character to help lead our organization now and into the future.

Our interns receive professional mentorship and leadership development opportunities to support future career growth with us. Whether you're looking to come back as a repeat intern, transition into one of our Leadership Development Programs, or pursue a full-time position post-graduation, we are here to support your next step!

Impact

Our interns are matched to projects based on their abilities and current business needs. All projects will have significant strategic and/or operating importance to the business to which they are assigned.

Summer projects may include the following responsibilities:

The Intern will work with knowledgeable mentors as part of the Diagnostics Regulatory Affairs team, working on registration of IVD products throughout the globe.  The IVD products are diagnostic immunoassays for therapeutic drug monitoring and toxicology screening.      Interns will gain experience and exposure in supporting global product registrations, submissions and licensing compliance. You will be preparing, compiling, and organizing documents for regulatory submissions, including drafting reports and addressing questions from regulatory authorities including those in Asia Pacific, Latin America and Europe.Interns will work on projects to collate and summarize post market surveillance data and generate clinical evidence reports to support Thermo Fisher productsExposure in use of databases totrack product documentation and regulatory data, including Oracle, Master Control, and RegDesk. Problem-solving skills to identify and implement process improvements within the Regulatory workflows, including using AI.    Become a process owner; critically review specific processes with great attention to detail and proactively recommend opportunities for improvement.

Start Date: This internship is set to begin on either May 12th or June 16th, 2025 for a duration of 10-12 weeks – dependent upon student availability per academic calendars.

Compensation & Relocation: Our undergraduate Quality internships offer an hourly rate between $21.50 - $28.75 dependent upon the location you are supporting (aligned to respective cost-of-living guidelines). Additionally, a relocation stipend is offered in the amount of $5,000 if necessary. Student must be located 50+ miles away from the physical location of the internship to be eligible for the relocation stipend.

How will you get here?

Undergraduate student completing an Engineering, Law or Life Sciences-related degree between December 2025 and June 2026.0 years of work experience required; previous related internships preferred.Awareness of processes and considerations for working in a regulated field.Consistent track record of results demonstrating integrity, innovation, involvement, and intensity.Energized through championing change, driven in getting results, and savvy in navigating ambiguity.Excellent interpersonal and communication skills .Must demonstrate strong organizational skills and be able to handle multiple assignments simultaneouslyProficient in MS applications (Excel, Word, Outlook) and with ability to write clear, understandable technical documentationThis position is on site at Fremont, California facility

If this sounds like you, we'd love to hear from you.

To qualify, applicants must be legally authorized to work in the United States and should not require sponsorship (current or future) for employment visa status. Thermo Fisher does not offer employment in this position to holders of F-1, J-1, H-1, OPT, and CPT Visas for the purpose of obtaining practical experience.

Compensation and Benefits

The hourly pay range estimated for this position based in California is $21.00–$24.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

A choice of national medical and dental plans, and a national vision plan, including health incentive programs

Employee assistance and family support programs, including commuter benefits and tuition reimbursement

At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

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