Job Information
Danaher Corporation Professional, Regulatory Affairs in Koto-Ku, Japan
Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics 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 Affairs Senior Specialist for Beckman Coulter Diagnostics is responsible for leading regulatory submission process for both IVD and MD to contribute expansion of business in addition to maintenance of product registration and related licenses like MAH or manufacturing site through change control process, and also leading regulatory compliance for business issues arising from business function.
This position is part of the Commercial Quality and Regulatory Affairs located in Tokyo, Japan and will be hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.
You will be a part of the Regulatory Affairs and report to the Senior Manager, Quality & Regulatory responsible for regulatory submission and its maintenance. If you thrive in a fast paced role and want to work to build a world-class Quality, Regulatory and Clinical Affairs organization—read on.
In this role, you will have the opportunity to:
To lead a new registration/regulatory change administration for In Vitro Diagnostics (IVD) and Medical Devices (MD) and discuss with Japanese regulatory agencies (PMDA/MHLW).
To lead documentation and administration for documents relevant to Regulator Affairs (e.g. IFU/package insert/product label, regulatory description for products, Product Master Formula)
To lead regulatory compliance for business issues arising from business function. (e.g. advertisement and promotion materials for products)
To lead clinical trial for IVD registration and discuss with clinical sites or commercial laboratories.
To lead administration of manufacturing sites relevant to IVD/MD marketing approval.
To lead a new registration/re-registration and administration for QMS on IVD/MD marketing approval
To discuss and collaborate with counterparts of overseas headquarters/production and development sites. To lead/support company’s projects from a country/global side. (e.g. DBS Kaizen project)
To support Commercial Regulatory Manager.
The essential requirements of the job include:
Experiences and knowledge of IVD and/or MD industries including registration
Deep knowledge of PMDA Act (including related ministerial ordinances
Experience of discussion/negotiation with regulatory agencies.
Communication skill and Leadership ability. Cooperative and team-work skill. Highly motivated and flexible to a new environment.
Business or Intermediate level English (Frequent communication in English by e-mail, teleconference, etc.) and native level Japanese
At Beckman Coulter Diagnostics 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 of the time at the Company location identified above and part of the 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 Beckman Coulter Diagnostics 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.