Sr. Manager Regulatory Affairs for Digital DX & Health IT in Sunnyvale, California at Cepheid

Date Posted: 11/8/2019

Job Snapshot

Job Description

Job ID: CEP004633

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 Senior Manager, Regulatory Affairs for Digital Dx & Health IT responsible for leading the regulatory affairs function for the digital diagnostics and health IT initiative. This will tie our existing diagnostics tests together in an aggregated digital offering such as an early risk-score, clinical decision support or similar delivered into the existing digital health eco-system. The Senior Manager, Regulatory Affairs for Digital Diagnostics & Health IT within DHR Dx will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with an initial focus on the US followed by an international expansion. Using specific disease states and their related treatment pathways as the driving use-case the team must define the right strategy and develop unique and differentiated insights that will help drive improved patient outcome. Our first digital diagnostics solution is powered by a machine learning algorithm for detecting and predicting sepsis onset, and this individual will lead us through the US FDA regulatory pathway for this trailblazing solution as an SaMD while establishing a regulatory roadmap for future digital DHR Dx solutions. This role will help shape the future of healthcare while ensuring DHR will have a winning position in the future healthcare eco-system.

Essential Job Responsibilities
  • Responsible for regulatory project timelines and management of regulatory submissions of our Digital Dx solutions
  • Lead regulatory activities including planning and reviewing of regulatory submissions.
  • Coordinate and prepare regulatory submissions to ensure compliance with regulations and guidelines.
  • 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 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
  • Provide regulatory assessments for anticipated analytical, manufacturing and packaging changes.
  • 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
  • Assess corrective action to assure it prevents recurrence
  • Provide regulatory training to cross-functional groups

Training Responsibilities (Required)

  • Complete all assigned and required training satisfactorily and on time
  • For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.

Job Requirements



Qualifications

Minimum Requirements

Education and Experience (in years): 
  • Bachelor’s degree in a Life Science or related field with 12+ years of experience OR Master’s degree with 8+ year of experience OR Doctoral degree with 5+ years of experience
  • A minimum of 5-6 years of experience in regulatory affairs for digital health solutions
  • A minimum of 3-5 years project management experience
 Knowledge and skills: 
  • Must be detail oriented with well-developed organizational and analytical skills
  • 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 digital health solutions
  • Strong understanding of digital technologies, including AI, ML, mobile, web, etc.
  • Working knowledge of agile development methodologies
  • Experience establishing/operating regulatory processes for agile software development environments
  • 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
PREFERRED REQUIREMENTS:
  • IVD product experience is highly preferred

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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, 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.