Ra Officer
4 months ago
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 **RA Officer** for Leica Biosystems is responsible for registrations of all in vitro diagnostic devices in the LBS portfolio for assigned countries within EMEA region.
This position is part of the Regulatory Affairs Department located in Newcastle, UK and will be a hybrid role. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives.
You will be a part of the Global Registrations EMEA Team and report to the Regulatory Affairs Director responsible for ensuring regulatory compliance for all IVD devices. If you thrive in a fast-paced role and want to work to build a world-class medical device organization—read on.
**In this role, you will have the opportunity to**:
- Manage registration projects, use Visual Daily Management and other necessary DBS tools for communication and problem solving
- Collaborate with Regulatory Affairs associates globally at each manufacturing site to support product registrations including market expansions, product changes and renewals in EMEA region
- Issue Product Release Notifications following successful license approval to enable devices to be launched to the market
- Provide Regulatory Affairs support for site QMS audits by Notified Body, Danaher and other regulatory bodies as required
- Participate and cooperate in the global Vigilance process, provides the vigilance reporting requirements for the assigned countries within EMEA region
- Support Regulatory Intelligence process by gathering and keeping up to date the regulatory changes and updates of the assigned countries within EMEA region
**The essential requirements of the job include**:
- Bachelor’s degree in science, Medical or Regulatory Affairs, or other related discipline
- 1 years’ experience working in ISO 13485 regulated industry
- Knowledge of in vitro diagnostic device regulatory requirements, particularly IVDR
**It would be a plus if you also possess previous experience in**:
- UKCA marking and Swiss regulations
- Product registration in EMEA, including CIS region
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.
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.
If you’ve ever wondered what’s within you, there’s no better time to find out.
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