Regulatory Affairs Specialist in Sunnyvale, California at Cepheid

Date Posted: 3/8/2018

Job Snapshot

Job Description

Job ID: CEP001077

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at or follow us on Twitter (@CepheidNews).


Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls.


Regulatory Affairs Specialist will represent RA on project core teams and provide other department support for assigned projects

  • Participate in project core team meetings
  • Review study protocols and reports
  • Review draft product labeling.
  • Prepare FDA pre-submissions and 510(k) notifications
  • Ability to perform the majority of required duties with limited supervision.

Job Requirements



Education or Experience (in years):
  • Bachelor’s degree or equivalent
  • 5 years’ Quality and/or Regulatory experience in the IVD or medical device industry.

Knowledge and skills:
  • Familiarity with FDA and international regulations for IVDs and/or medical devices
  • Direct experience working with 21 CFR 820 and ISO 13485

  • 5 years Regulatory Affairs experience
  • RAC Certification (US)
  • Device industry experience representing quality or regulatory affairs on cross-functional project
  • teams
  • 510(k) and PMA experience (including annual reports, supplements)
  • Working knowledge of Directive 98/79/EC
  • Expertise with molecular technologies
  • Proficiency with Agile Product Lifecycle Management (PLM)

Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years.

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.