REGULATORY SPECIALIST II in Sunnyvale, California at Cepheid

Date Posted: 5/8/2018

Job Snapshot

Job Description

Job ID: CEP001046

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

Cepheid is a molecular diagnostics leader, committed to improving healthcare with our accurate yet easy-to-use GeneXpert® System, and our expanding portfolio of Xpert® tests which span healthcare associated infections and other infectious diseases, sexual health, virology and oncology.


With more than 9,000 GeneXpert Systems placed globally, Cepheid’s solutions envision a better way for clinical institutions of any size – from reference labs and hospitals to doctors’ offices and remote service providers - to access the full power of molecular diagnostics, enabling the delivery of rapid and accurate test results that can transform patient outcomes while also improving workflow and reducing costs for healthcare providers. As the demand increases for our solutions we are growing rapidly, and we are looking for talented people who share our vision to join our team.





REGULATORY SPECIALIST II





The Regulatory Affairs Specialist will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on Greater India and South East Asia countries. Assist with ROW submissions as required. Participate in international regulatory intelligence groups and represent Regulatory Affairs on the product life-cycle management teams as needed.





Responsibilities:



  • Generate regulatory reports to communicate worldwide registration activities

  • Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives

  • Interact with global regulatory leaders and peers to expedite approval of pending registrations         

  • Interact with departments to generate protocols and reports that require in-country testing data for registration purposes

  • Maintain a "focused urgency" as required by specific events  

  • Recognize potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors  

  • Assess potential impact and/or applicability to other related areas   

  • Assess corrective action to assure it prevents recurrence   

  • Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions  

  • Provide regulatory training to cross-functional groups   

Required Knowledge Skills and Abilities:



  • Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level

  • A minimum of 3-5 years of direct related experience in regulatory within an IVD or medical device manufacturing site

  • Sound basis of Regulatory and /or Scientific knowledge

  • Strong PowerPoint, Excel and Word knowledge

  • Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing     processes

  • Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations

  • Able to confidently deal with ambiguous issues and provide input towards suitable actions

  • Strong oral and written communication and presentation skills

  • Effective communicator of technical & non-technical information

  • Ability to work in a self-directed manner to see issues through to completion

  • IVD product experience is highly preferred

  • International submissions experience is preferred

Job Requirements



Qualifications

Required Knowledge Skills and Abilities:



  • Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level

  • A minimum of 3-5 years of direct related experience in regulatory within an IVD or medical device manufacturing site

  • Sound basis of Regulatory and /or Scientific knowledge

  • Strong PowerPoint, Excel and Word knowledge

  • Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing     processes

  • Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations

  • Able to confidently deal with ambiguous issues and provide input towards suitable actions

  • Strong oral and written communication and presentation skills

  • Effective communicator of technical & non-technical information

  • Ability to work in a self-directed manner to see issues through to completion

  • IVD product experience is highly preferred

  • International submissions experience is preferred


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.