Job description

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 Coordinator EM/EMEAI Beckman Coulter Diagnostics is responsible for the effective implementation of supplier and Economic Operator (EO) activities associated with the Emerging Markets/European multi-site ISO 9001 commercial operations certifications.

This position is part of the Quality Assurance & Regulatory Affairs located in Ireland (IRL) 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 Supplier and Distributor Quality team and report to the Regional Manager - Quality & Regulatory Affairs Turkey, Economic Operator EMEAI responsible for ensuring alignment with global BEC policies and procedures, for compliance with local and regional regulatory requirements in the context of supplier & EO control, and for supporting EM/EU commercial operations in the implementation and development of these policies, procedures and requirements.

If you thrive in a fast paced role and want to work to build a world-class Quality and Regulatory organization—read on.

In this role, you will have the opportunity to:
Activities
Communicate and maintain current TPP (Third Party Product) data base.
Coordinate and verify TPP products documents to create & release Regulatory Stop Ships for TPPs
Manage Regulatory change notices from Suppliers for the EMEAI (Europe, Middle-East, Africa, India) regions
Review / implementation of Economic Operator obligation agreements with suppliers (connections between Supplier Quality Agreement and EMEAI RA as well)
Facilitate communication with other EOs (initial calls, answering standard questions, etc..)
Reporting complaints to suppliers for Third Party Products (TPP) and initiate SCAR activities.
Partner with BEC Regulatory, Procurement, Purchasing and Sales departments to maintain a compliant TPP list.
Ensure monthly KPI’s completion & Dashboards.
Support the position of Regional Manager - Quality & Regulatory Affairs Turkey, Economic Operator EMEAI as needed.

Quality Management System Support Activities
Support the EMEAI Quality & Regulatory Organization to ensure successful fulfilment of EMEAI Commercial Quality objectives
Support the local ISO 9001 Quality Management System
Use DBS tools, and apply them to specific projects as required

The essential requirements of the job include:
University Degree in Science or equivalent
Experience of working in a commercial Medical Device or Pharmaceutical business setting.
Experience of working within a global, multi-cultural, matrix organization
Deep knowledge of IVDD, IVDR and related regulations
Fluent in English – written and verbal
High level of IT literacy, knowledge of Microsoft Office
At least 3-5 years experience

It would be a plus if you also possess previous experience in:
Working across cultures and regions
Influencing others without authority

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 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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