VP - Global Regulatory Affairs in Sunnyvale, California at Cepheid

Date Posted: 8/21/2019

Job Snapshot

Job Description

Job ID: CEP003718

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

Scope


This position will provide strategic and operational leadership to the global Regulatory Affairs organization; lead the overall regulatory aspects from regulatory path planning to regulatory submission plus post market regulatory change assessment.  This role  oversees Regulatory system and Regulatory operations for Cepheid’s overall product portfolio: reagent, assay, HW, SW, system, consumable, product label and labeling as well as sustaining programs pertaining to regulatory affairs to meet US FDA, IVDD/IVDR, ISO13285 and global product registrations requirements. 


The Vice President, Global Regulatory Affairs will build strong, effective and diverse teams to support the global regulatory landscape; anticipate and lead the regulatory org to stay ahead of the rapidly growing global regulatory environments; guide Cepheid’s regulatory path and strategy on new product development; build strong working relationship with US FDA and global regulatory agencies and competent authorities; maintain regulatory intelligence; represent Cepheid  to interface with US FDA and global regulatory agencies.


The Vice President, Global Regulatory Affairs will report to the Senior Vice President, Quality Regulatory and Clinical Affairs (QRC)..

Principal Responsibilities:

  • Design and direct pre-market and post-market regulatory strategies for multiple operations and successfully manage complex issues which have significant impact on the business.

  • Develop and implement advanced and aggressive regulatory strategies enabling development centers to operate competitively while managing regulatory activities.

  • Build and develop a high performing global regulatory team.

  • Work with business teams to anticipate the impact of current and emerging trends, identify potential opportunities or threats against the company.

  • Ensure company practices are consistent with corporate regulatory risk posture.

  • Represent Cepheid on industry and company-wide Regulatory committees and regulatory organizations.

  • Manage communications with regulatory agencies in Canada, the EU, the U.S., and other global regulatory agencies for all geographic areas as needed.

  • Initiate tactical, cross-functional and local process improvement teams to define initiatives to achieve organizational process improvement.

Job Requirements



Qualifications

EXPERIENCE DESIRED:
  • Must have a Bachelor’s degree with 20+ years of experience or a Master’s/Doctoral degree with 18+ years of experience and 6+ years managing people.
  • Broad Regulatory Affairs experience working with the US FDA and global regulatory agencies in the In Vitro Diagnostics Industry.
  • Demonstrated track record of successful regulatory submissions.
  • Experience leading a global organization with a strong track record of building and developing teams.

  • Demonstrated knowledge and understanding of global regulations and guidelines governing the areas of medical device and diagnostic development.

  • Experience in the development, registration and commercialization of medical device and diagnostics products; experience in molecular diagnostics products is preferred.

  • Ability to develop effective regulatory strategies and apply regulations to pre-market and post-market strategies.

  • Possesses a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development.

  • Experience working globally and with global teams.

CRITICAL COMPETENCIES:

  • Strategic thinker able to address complex situations and issues.

  • Express abstract and controversial ideas clearly and effectively; ensure communications, key decisions and strategies are understood in all settings.

  • Act decisively, support beliefs and challenge others appropriately.

  • Organize, facilitate and train cross-functional teams and business unit teams to achieve results; collaborate across the organization and work in high level teams; manage matrices effectively.

  • Develop strategic goals and objectives from knowledge base and understanding of a customer’s business.

  • Manage changing conditions, processes and approaches; lead organizations through change effectively.

  • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.

PERSONAL SKILLS / ATTRIBUTES:

  • Leadership:  Possess demonstrable leadership skills; has the ability to move others to action, including peers, superiors and subordinates. Demonstrate a positive, results-oriented style.   Able to develop, and manage performance, of team through coaching and feedback, willing/able to share personal knowledge and experience with others.

  • Communication Ability:  Ability to develop and articulate an effective flow of ideas and information that generates understanding and creates a climate in which others are informed and want to participate.

  • Courage:  Not afraid to stand up for his/her beliefs or voice an unpopular opinion. Willing to try new ways without fear of failure.  Challenges the status quo.  Takes stands to resolve important issues. 

  • Planning and Analyzing Skills:  Use an analytical approach; evaluate a situation from varying perspectives to create well-reasoned solutions.

  • Interpersonal Skills:  Able to foster excellent relationships and credibility quickly at all levels of the organization. An ability to create a partnership atmosphere with internal and external resources while achieving key operating objectives.

  • Customer Focus:  This individual needs to understand company’s customers and competition to maximize opportunities and advantages, and search for ways to leverage the current position.

  • Results Focused:  A confident individual who provides a good balance of risk taking and sound judgment in order to deliver optimal results.

  • Character: A professional of unquestionable integrity, credibility and character who has demonstrated high moral and ethical behavior.


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 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 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.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.