Principal Regulatory Specialist in Sunnyvale, California at Cepheid

Date Posted: 9/23/2018

Job Snapshot

Job Description

Job ID: CEP001110

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 www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

The Principal Regulatory Affairs Specialist will represent RA on project core teams, provide department and inter-departmental support for assigned projects, and be responsible for regulatory submissions and their clearances/approvals


ESSENTIAL JOB RESPONSIBILITIES:



  • Actively participate in project core teams and strive to collaboratively achieve project goals and meet timelines


  • Critically review study protocols and reports to assess quality, clearly identify gaps, and provide mitigations


  • Compile, prepare, review, and submit regulatory submissions including FDA pre-submissions and 510(k) notifications


  • Actively manage and monitor submissions under review. Respond promptly and negotiate with regulatory authorities, as needed. Track and manage regulatory review timelines.


  • Provide regulatory input to product lifecycle management


  • Interface with Engineering, Product Transfer, and Manufacturing to provide regulatory input for various continuous improvement projects


  • Perform the majority of required duties with limited supervision. Provide periodic updates on status of projects.


  • Interpret federal/state/international regulations as they apply to our products, processes and/or procedures. Advise on impact of regulations, devise strategies for compliance, and liaison with regulatory bodies. Investigate and resolves compliance problems, questions and complaints. Audit and evaluate current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and 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.

Job Requirements



Qualifications

MINIMUM REQUIREMENTS:

Education or Experience (in years): 



  • Bachelor’s degree or equivalent


  • At least 7 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


  • Experience with in vitro diagnostic products and molecular technologies


  • Technical writing skills and ability to review and summarize data into clearly written reports


  • Working experience with statistics programs (JMP/Minitab) and familiarity with data analysis interpretation


  • Strong inter-personal skills and an ability to effectively communicate complex ideas and concepts to a diverse audience

PREFERRED REQUIREMENTS (optional):



  • 5 years Regulatory Affairs experience


  • 510(k) and PMA experience (including annual reports, supplements)


  • Proficiency with Agile Product Lifecycle


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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.