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Director, Regulatory Systems in Sunnyvale, California at Cepheid

Date Posted: 1/10/2019

Job Snapshot

Job Description

Job ID: CEP002737

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 Director of Regulatory Systems will provide management and overall strategic direction and operational coordination of activities for Regulatory Affairs. He/She will ensure compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements.
This position will interface with Research and Development Operations, Clinical Affairs, Regulatory Affairs, Government Affairs, and Marketing. To assure that regulatory systems are is properly developed and documented for US and International registrations / submissions.
This positon will require development and managing the following systems; marketing, advertising, promotions, sales, and science; research use only, regulatory change assessment, labeling change control and regulatory Intelligence.

Responsibilities

  • Provide guidance in regulatory activities including planning and reviewing of regulatory submissions.
  • Participate in regulatory project timelines and management of global regulatory submissions. 
  • Develop processes and SOP’s to provide the organization clear regulatory requirements.
  • Keep abreast of new regulatory requirements related to US and international stet.
  • Assure that all Marketing collateral is consistent and has approved labeling according to regulatory agency directives.
  • Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives.
  • Provide proactive regulatory intelligence in areas of a competitive nature and also keep abreast of changes in agency regulations and requirements.
  • Interact with global regulatory leaders and peers to expedite approval of pending stet.         
  • Support RA functional area in the review and approval of Change Orders.
  • Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials as needed.
  • 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. 
  • Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions. 
  • Assess potential impact and/or applicability to other related areas.   
  • Provide regulatory training to cross-functional groups.
  • Approve Research Use Only (RUO) studies for global research.  

Job Requirements



Qualifications

Required Knowledge Skills and Abilities:

  • IVD product experience is required. Molecular diagnostics experience preferred.
  • Bachelor’s degree (with 9+ yrs experience) in a Life Science preferred. Or, equivalent combination of education and experience to perform at this level, PHd degree preferred.
  • A minimum of 5-8 years of experience in regulatory/Quality or related departments within an IVD or medical device industry
  • A minimum of 1-2 years management experience with at least 2-3 direct reports
  • Must be detail oriented with well-developed organizational and analytical skills
  • Highly proficient in Microsoft Word, Excel, Power Point and Adobe Acrobat
  • Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment
  • 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
  • Extremely detail oriented with strong organizational skills, and high quality standards.

Physical Demands

  • Capability to complete routine office activities.
  • Comfortable with periodic, long-distance air travel to satellite facilities.


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.