Regulatory Affairs Support Coordinator

Cepheid is a molecular diagnostic company dedicated to improving healthcare by developing, manufacturing and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, Cepheid is focusing on applications where accurate, rapid and actionable test results are needed most, such as managing infectious diseases and cancer.
Make a difference in healthcare and join us on this mission!


POSITION SUMMARY:
The Regulatory Affairs Support Coordinator assists the Regulatory Affairs team with EU and international submissions and coordinates the activities that are essential for an efficient functioning of the department.


ESSENTIAL JOB RESPONSIBILITIES:
Coordinates and catalyzes the legalization of documents to support international registration activities
Implements documentation, file updates and archiving
Provides informal guidance and support to more junior team members
Supports onboarding and integration of new team members
Updates the team’s VDM chart (virtual) at least weekly or real-time
Implements purchases of material and services (thru ibuy)
Catalyzes the process of establishing contracts (icontract)
Supports the planning and organization of live and virtual team meetings and trainings and travel as required
Maintain a "focused urgency" as required business needs



Requirements:
Able to manage multiple priorities and thrive in a fast-paced team environment.
Able to function independently with minimal supervision.
Able to function under pressure and meet regular deadlines.
Excellent verbal and written communication skills in English and Swedish
Flexible, with ability to address urgent requests even beyond normal office hours.
Highly proactive, outward going, organized, service minded and result oriented.



Cepheid is part of Danaher Corporation, a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders.
Come join our winning team!


When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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.
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