Job Information
Danaher Corporation RA intern in Amsterdam, Netherlands
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 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 Regulatory Affaires intern for Leica Biosystems is responsible for conducting research on regulatory requirements in various countries and to improve our global registration process.
This position is part of the RA team located in Amsterdam, the Netherlands and will be hybrid.
You will be a part of the QARA department in LBS-AMS and report to the Sr. RA Specialist responsible for conducting research on regulatory requirements in various countries and to improve our global registration process, and working on our projects. If you thrive in a multifunctional, international role and want to work to build a world-class regulatory affaires organization—read on.
Research topic: Control of global registration and product release
IVDs are tests used on biological samples to determine the status of a person’s health. They play a crucial role in diagnosing, preventing, monitoring, predicting, and treating diseases (https://health.ec.europa.eu/medical-devices-sector/overview_en ), contributing to improving public health. Examples of IVDs include self-tests for pregnancy, COVID-19 tests, cancer genetic tests, or high-throughput testing of blood donations for infections such as HIV, performed in clinical laboratories. Due to the importance of IVD products for improving public health, regulatory frameworks have been developed by regulators in many countries/ regions to regulate these products, and lots of efforts have been made to harmonize frameworks with other countries/ regions. However, differences and discrepancies in regulatory pathways still exist.
As a global IVD company that markets large number of products all over the globe, it is vital to understand these differences across these markets and set up internal processes to ensure the fulfillment of regulatory requirements in these markets and have control over global registrations.
This research internship will be primarily focused on understanding regulatory requirements and the control of global registration, the deliverables (deliver together with supervisor) will be a comparison study between a selection of countries, and an internal process for the control of global registration (Standard Operating Procedures/ Work Instructions etc). The details of the research project can be discussed with the organization, with possibility to make small adjustments. In addition, the organization will provide reimbursement.
Disclaimer: this is a 6 -9 month full-time (or 32/ 36 hr, negotiable) research internship program combined with projects of the company, the intern will be required to work on projects to acquire hands-on experience as foundation (50% time) of the regulatory role. The intern will be supervised by a Senior Regulatory Affairs Specialist.
In this role, you will have the opportunity to:
Complete a research internship (thesis) with the help of the organization.
Choose to participate in various interesting projects that interest you.
Gain knowledge and hands-on experience in regulatory affairs that might open a door for you to regulatory affairs.
Acquire work experience and sharpen your organizational skills that prepare you for a real job.
Work in an international and inclusive environment with friendly and supportive colleagues.
The essential requirements of the job include:
Great attention to detail, analytical/ critical thinking, down-to-earth and be proactive.
Bachelor’s student in Beta Science/ policy analysis/ law/ business and relevant subjects, great commend of English and Microsoft Office, good problem-solving skill.
It would be a plus if you also possess previous experience in:
Scientific writing, regulatory affairs/ quality assurance role
Would be a plus if you are a faster learner and have command of second/ third language, good time and project management skills.
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.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
At Danaher, 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.