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Danaher Corporation Vice President, Global Regulatory Affairs in Sunnyvale, California

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Vice President, Global Regulatory Affairs is responsible for the development of policies, strategy, and programs including monitoring mechanisms to ensure the Company’s pre- and post-market regulatory programs and related business activities comply with all global product regulations across multiple development centers and geographic locations.

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, assays, 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 for In Vitro Diagnostics (IVD) medical devices.

In addition to Regulatory technical core competency evidenced by successful regulatory submission track record, this leadership position will be a thought partner to Business Units’ leaders within Cepheid to help layout regulatory landscape, strategize regulatory framework and advice on regulatory pathways to accelerate business growth through strong partnership.

This position is part of Global Regulatory and will be preferably located in Sunnyvale, California; remote or hybrid working can be considered. Global Regulatory Affairs achieves and maintains global product registrations to positively impact health, safety, and quality of life for people around the world.

In this role, you will have the opportunity to:

  • 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 with both a local and remote workforce.

  • 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.

The essential requirements of the job include:

  • Bachelor’s degree with 20+ years of experience or a Master’s/Doctoral degree with 18+ years of experience and 6+ years managing people.

  • Experience working with the US FDA and global regulatory agencies in the In Vitro Diagnostics Industry with molecular diagnostics preferred.

  • Demonstrated track record of successful regulatory submissions including PMA, De Novo, 510(k) and CLIA waivers. Knowledge and understanding of global regulations and guidelines governing the development and pre-market authorization medical devices.

  • Ability to develop effective least burdensome regulatory strategies and apply risk-benefit approach to maximize the effectiveness of pre-market and post-market regulatory strategies.

  • Broad knowledge of surrounding areas including Quality Assurance, Clinical Affairs, Medical Affairs, Product Development and Manufacturing.

  • Experience in working and leading global teams along with a remote workforce. Strong track record of building and developing high performing associates and teams.

  • Experience in the development, registration and commercialization of medical device and diagnostics products

It would be a plus if you also possess previous experience in:

  • Registration of instrument and software as medical device (SaMD); experience in regulatory change management.

  • Molecular diagnostics infectious disease and oncology products.

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.

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When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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