Regulatory Affairs Principal Engineer at Cepheid in Sunnyvale, California

Job Description:

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System which makes everything possible.

The Principal RA Engineer serves as RA lead on New Product Development (NPD) core teams, working on medium to complicated instrument, software projects, system projects or assay projects.

This position is part of the Regulatory Affairs department and will be located in Sunnyvale, CA. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

Prepare regulatory submissions and interacts cross-functionally to ensure OTD of product launches.

Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required.

Provided guidance on safety and regulatory matters throughout the design, manufacturing, and inspection processes, ensuring international market approvals.

Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU.

Implements continuous improvements and efficiencies using DBS tools.

The essential requirements of the job include:

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  Bachelor's degree in field with 8+ years of related work experience OR Master's degree in field with 6+ years of related work experience OR Doctoral degree in field with 3+ years of related work experience

  
  


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  Serves as RA lead on new product (NPD) core teams including medium to complicated instrument, software projects, systems or assays and submissions (510(k), De Novo, Class 1, 2 & 3).

  
  


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  Possesses a high level of technical understanding of hardware, software, wireless connectivity, and safety guidelines and regulations such and RoHS, REACH, and EMC testing requirements.

  
  


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  Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions that are in scope for the initial product launch (US, EU, WHO/PQ).

  
  


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  Authors and prepare regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan.

  
  

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

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  Compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions.

  
  


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  Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations.

  
  


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  Experience with HW and SW testing including EMC and safety testing.

  
  

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

The salary range for this role is $143,400-197,100. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Join our winning team today. Together, we'll 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.

For more information, visit

www.danaher.com
.

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 applyassistance@danaher.com to request accommodation.

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