Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Leica Biosystems, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Principal Specialist, Regulatory Affairs is responsible for ensuring new or sustaining products receive regulatory approvals within a timely manner by hands-on communication with MHLW and PMDA (both IVD Class II and Class III and medical device Class I and Class II). Furthermore, this position will be responsible for GVP, ensuring appropriate monitoring of internal or external events related to product quality and to provide the necessity pharmacovigilance report to local governance by complying with local regulations, industry and OpCo standards.
In this role, you will have the opportunity to:
+ Act as the MAH GVP Responsible Person for both IVD and medical devices, ensuring compliance with local regulations and lifecycle management.
+ Collaborate with BU and SU stakeholders to manage quality issues, including administration of field actions (recalls) and complaint system reporting.
+ Maintain and update GVP documents based on regulatory changes; support all related licenses (e.g., MAH for IVD/medical devices, poisonous substance import, device maintenance).
+ Lead preparation of STED documents for both IVD and medical devices, and manage PMDA consultation documents and responses to queries.
+ Organize and lead internal GVP meetings as needed, ensuring alignment across teams and timely communication of regulatory requirements.
The essential requirements of the job include
+ Hold a Pharmacist License.
+ 7+ years experience in regulatory affairs for medical devices or lifescience products with 5+ years people management experience preferred.
+ Strong english communication skills, client service orientation and ability to work cross functionally
+ Solid understanding of healthcare business, strong project management and leadership capabilities to influence and organise across groups
+ Skilled in MS Excel, Powerpoint, familiarity with PMDA DTD system is a plus.
Travel Expectations for this role are <10%.
Join our winning team today. Together, we’ll 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.
For more information, visit www.danaher.com .
