Job Description

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Join a team where you can be heard, be supported, and always be yourself. At Beckman Coulter, a Danaher company, were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. We are dedicated to advancing and optimizing the laboratory to move science and health care forward for more than 80 years. Find the opportunity to build relevant career, be creative, and try new things with the support needed to be successful. Find the Danaher Business System, which makes everything possible.

We hope youll see yourself here, too. What you find at Beckman Coulter and within yourself might just change the world!

The Regulatory Affairs Analyst II, for Beckman Coulter Diagnostics is responsible to coordinate, facilitate, and report on post-market regulatory programs for field actions and related design changes, worldwide registrations and support of post-market activities for marketed products.

This position is part of the Regulatory Affairs department and will be located in Chaska, MN.

As a member of the Regulatory Affairs team, this role is responsible for assisting with re-registrations for products sold around the world. If you thrive in a team role and want to work to build a world-class regulatory organizationread on.



In this role, you will have the opportunity to:

* Coordinate and manage the post-market regulatory reporting and compliance activities in accordance with company procedures and regulatory requirements.
* Create, monitor and control regulatory project schedules related to post-market activities.
* Key accountability is to maintain global regulatory compliance programs for product corrective action, vigilance requirements, stop ship in Oracle, and supporting global registration processes.
* Coordination of on-going regulatory activities with Corporate Quality and Regulatory Affairs and coordinating and communicating with domestic and international business partners and direct interaction with regulatory agencies on post-market product issues and questions
* Exercise judgment within defined procedures and practices to determine appropriate action and influence teams and functions on requirements for maintaining compliance.
* Monitors policies, procedures and standards relating to Regulatory Affairs, evaluates impact and communicates to interested parties.
* Recommends changes to improve practices and procedures.





The essential requirements of the job include:

* A Bachelors degree with 2+ years of experience, Masters or Doctoral degree with 0+ years of experience. Preferably in areas of life sciences, engineering, or quality assurance.
* Experience in Regulatory Affairs documentation and/or registration activity.
* Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQE, CQA, RAC, Six Sigma, Lean Principles)

Beckman Coulter, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to associates lives. Whether its a health care program or paid time off, our programs enhance life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

Work hard and with guidance from committed leaders, powerful DBS tools, and the support of a global organization. As part of Danaher's 67,000 associates across the globe, the possibilities for growth and development are unparalleled.

We believe that creativity and innovation thrive when the most diverse set of voices are heard, and thats why were taking concrete steps to ensure that were fostering an inclusive and engaging workplace. To learn more, read about our associates on our Careers Blog or contact one of our recruiters.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.