Regulatory Affairs Associate

1 month ago

New Brighton, Minnesota, United States Danaher Full time

In our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating impactful innovations like ours, doesn't happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer 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.

Location: This position is eligible for a hybrid work arrangement in which you can work part-time at the Minnesota MN or Carlsbad, CA location and part-time from your home.

The Regulatory Affairs Associate is responsible for regulatory assessments, plans for design control activities, and regulatory approvals of design documentation. Support regulatory compliance requirements of US, EU, and other international standards. The RA Associate will also assist with post-market activities including post-market surveillance, adverse event reporting, and field actions. The RA Associate will support review and update of labeling for regulatory compliance.

You will be a part of the Quality Assurances and Regulatory Affaris Team and report to the Senior Manager, QARA responsible for regulatory Compliance. If you thrive in a multifunctional and fastpaced role and want to work to build a world-class QARA organization—read on.

In this role, you will have the opportunity to:

  • Support Regulatory activities for escalated complaints
  • Support Regulatory assessment of document control, validation, labeling and other documentation as necessary
  • Participate in process improvements, global alignment projects and creation of SOPs in the RA area and learn from best practices in DHR/Radiometer/Industry.
  • As assigned, supports the preparation of documents for applications (including amendments/supplements), registrations, adverse events and medical device reporting, and responses to regulatory agency questions.
  • Assist with and act as a resource for regulatory inspections.

The essential requirements of the job include:

  • BS/BA Degree.
  • Experience working with multi-functional teams.
  • Analytical and able to handle complex situations. Focused on targets and results.
  • Strong administrative and interpersonal skills. Proficient in Microsoft Office with Excel, PowerPoint and Word.

It would be a plus if you also possess previous experience in:

  • BS/BA in Pharmacy, Biology, or Engineering preferred.
  • A medical manufacturing environment preferably in Quality Assurance or Regulatory Affairs.
  • Fluent in Chinese Language.

At Radiometer 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 Radiometer can provide.

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. 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.

The EEO posters are available here.

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

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