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Danaher Corporation Sr. Regulatory Affairs Specialist in Sunnyvale, California

At Cepheid, we are passionate about improving health care through faster, more accurate diagnostic tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us, every moment of every day, as we develop rapid groundbreaking solutions to solve the world’s most complex health challenges.

Our associates are involved in every stage of molecular diagnostics ­ ­­– from ideation and innovation through development and delivery of life-changing advancements in healthcare-associated infections, sexual health, critical infectious disease, virology and oncology applications. For more details, visit us at www.cepheid.com or follow us on Twitter. (@CepheidNews)

As part of the Danaher family of companies, our work at Cepheid is supported by a global science and technology innovator. In addition to Danaher’s unrivaled leadership training and professional development programs, this relationship also provides expanded career opportunities across industries and brands. Together, we are united by a shared purpose: Helping Realize Life’s Potential.

POSITION SUMMARY:

The Senior Regulatory Affairs Specialist will represent RA on project core teams, perform the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections. Compile all materials required in submissions, license renewal, and annual registrations. Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Keep abreast of changes of new or updated regulatory policies and issued guidance.

RESPONSIBILITIES

  • Responsible for generation and maintenance of regulatory files

  • Responsible for generating and delivering documentation for registration of Cepheid products

  • Partner with global and regional marketing in the development of regulatory plans

  • Manages and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas

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

  • Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas

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

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

  • Assesses corrective action to assure it prevents recurrence

  • Formulate short-term planning for individual deliverables and participate in long term planning within the organization

  • Prepare formal written reports/documents for distribution within work unit and regions

  • Provide training or presentations in multiple disciplines to cross-functional groups

MINIMUM REQUIREMENTS

Education and Experience:

  • Bachelors degree in a scientific discipline or related field is preferred. Or, equivalent combination of education and experience to perform at this level

  • A minimum of 5 years experience in a fast paced regulatory/compliance/quality team at a medical device manufacturing site

Knowledge and skills:

  • Sound basis of Regulatory and /or Scientific knowledge

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

  • Domestic submissions with 510K

  • Experience working with Design Dossier and CE Marking

  • 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 industry experience is highly preferred

  • Molecular diagnostics industry experience preferred

  • 2+ years’ experience in regulatory affairs

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid

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