Chemistry/ Biology Reg Affairs Internship - San Diego, California
Please note that this is an internship. Internships are for current college students. If you have graduated, you should not be applying for this role.
Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.
Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.
Leica Biosystems (LBS) is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The STEM Intern will be part of the Regulatory Affairs and Quality Assurance Team. Supporting the engineering and manufacturing of Digital pathology scanners, which are high precision and automated electro-mechanical instruments for high resolution scanning of pathological samples. Our vision is to advance cancer diagnostics and improve lives.
This is a hybrid role, based out of Vista, CA. At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team.
In this role, you will have the opportunity to:
- Assist the regulatory department in the generation, formatting, and preparation/publishing or review of regulatory submissions or non-submission documents (paper or electronic).
- Attend global regulatory affairs and cross-functional project team meetings to gain knowledge of the business interworking of a large global IVD organization.
- Participate on project teams and may lead specific regulatory tasks, under the guidance of senior staff
- Assist in the evaluation of change control documents for impact on submissions and filing requirements
- Collaborate with quality assurance to manage, 21CFR compliance and design control programs and other regulatory bodies
- Ensure regulatory compliance with QSR, and other regulatory requirements as appropriate through customer complaints, internal audits, and training systems
- Assist in developing procedures to ensure regulatory compliance
- Assist with regulatory database development and maintenance
The essential requirements of the job include:
- Completed Bachelor's degree in a scientific discipline is required, Masters in Regulatory Affairs degree candidate preferred
- Strong organizational and planning skills
- Strong knowledge of MS Office Suite - Word, Excel, PowerPoint
- Exceptional communication in English - verbal and written
- Must be detail- and goal-oriented, quality conscientious, and results-oriented
- An ability to manage changing priorities, multiple tasks, and communicate impact to project teams is required
At Leica Biosystems we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Leica Biosystems can provide.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.