Danaher Corporation (Junior) Global Commercial QRA Analyst (f/m/d) in Prague, Czech Republic
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 (Junior) Global Commercial QRA Analyst for Beckman Coulter Diagnostics is responsible for planning and coordinating the registration of Third Party Products for which Beckman Coulter is a distributor throughout the world.
This position is part of the Commercial Regulatory Affairs organization and follows the hybrid work model. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time. this position can be based in one of the following locations and will be hybrid: Prague, Zagreb, Budapest or Warsaw.
You will be a part of the EU & METAM Commercial Regulatory Affairs team and report to the Regulatory Affairs Manager for EU & METAM responsible for pre and post market Regulatory Affairs. If you thrive in a fast-paced global role and want to work to build a world-class regulatory affairs organization—read on.
In this role, you will have the opportunity to:
Act as the single point of contact between Country Regulatory Affairs and Third Party Manufacturers to plan and obtain and maintain regulatory documentation necessary for market access globally
Collect documentation necessary to demonstrate compliance to the obligations ascribed to distributors and importers under the in-vitro Diagnostic Regulation 2017/746 and Medical Device Regulation 2017/745
Support the EU & METAM Regulatory Organization (pre and post market) to ensure successful fulfilment of EMEAI Commercial Quality & Regulatory objectives and stay up-to-date with changes in regulatory legislation and guidelines (global)
Leverage the Danaher Business System (DBS tool kit) to improve, review, refine and adjust associated tools and procedures including continued development of the Third Party Product database
Develop close connections with Product Management, Alliance Management and Supplier Quality Assurance to understand, comply with and, where necessary update, contractual arrangements
The essential requirements of the job include:
a University Degree (Bachelor or Master) in Science or equivalent
1 -3 years experience working in a registration department, regulatory agency or another related environment in the in-vitro diagnostic medical device industry
Excellent communication skills and fluent English language skills – written and verbal, additional languages are a plus
High level of IT literacy, knowledge of Microsoft Office
Ability to learn quickly, diligent, comfortable working under pressure within time constraints and to deadlines
It would be a plus if you also possess previous experience in:
Registering in-vitro Diagnostic Medical Devices within EMEAI and / or LATAM and / or JAPAC
Working within a global, multi-cultural, matrix organization
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-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 Beckman Coulter Diagnostics 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 (https://www.danaher.com/how-we-work/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.