- Provide guidance to product development and product life cycle management under direction of Design Control
- Act as representative for all Quality Management activities for new product development projects;
- Documentation for IVDR, customer requirements, product requirements, design and development plans and reports, non-clinical protocols and reports, design transfer documents, labeling, clinical plan and reports, risk management plans and reports, project plans and milestones;
- Convey information from meetings and other communications to Quality Management to inform management of critical issues and to assure consistent feedback to teams which is in alignment with Quality Management policy;
- Participate in discussions, challenge the status quo, and identify mutually beneficial compliant solutions/compromises with cross functional colleagues at the Project Team level. Work closely and partner with Danaher and LBS colleagues in product development teams with the goal of leveraging expertise and alignment on best practices;
- Bachelor's or Master ́s Degree in Chemistry, Biochemistry, Molecular Biology or related scientific discipline or equivalent combination of education and work-related experience.
- A minimum of 2-3 years of experience in regulated industry – in-vitro diagnostic (IVD) products or related medical devices, pharma or clinical research – with high involvement in the new product development or leading new product development;
- Good familiarity with Design Controls and ISO: ISO 13485 and Risk Management ISO 14971;
- Experience with human cytogenetics and/or (F)ISH (Fluorescent In Situ Hybridization), histological/ immunohistochemical, pathology and molecular biology techniques and their use in clinical diagnostic settings is highly desirable;
- Excellent communication skills and full working proficiency in the English language (C1 level) is essential, any other language proficiency is a plus.
- Strong track record of successful participation in cross-functional teams and projects;
- Knowledge of or affinity with quality regulations, medical devices, clinical or pharma processes is preferred;
- Knowledge of the main regulations, such as EU IVDR and/or MDR, EU IVDD and/or MDD is highly desirable;
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In-vitro diagnostics Scientist - Amsterdam, Nederland - Danaher
Beschrijving
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 In-vitro Diagnostics Scientist for Leica Biosystems is responsible developing, deploying, and maintaining robust and compliant quality-by-design processes and to support new product development projects according to applicable regulatory requirements and standards - all to contribute to Leica's growing business.
This position is part of Leica Biosystems located in Amsterdam and will be mainly on-site, but working remotely is a possibility. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.
You will be a part of the R&D team and report to the R&D manager responsible for developing, deploying, and maintaining robust and compliant quality-by-design processes and to support new product development projects according to applicable regulatory requirements and standards. If you thrive in a multifunctional role and want to work to build a world-class R&D organization—read on.
In this role, you will have the opportunity to:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in:
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
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.
