International Regulatory Affairs Information

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CEPHEID

Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is f... Read More

Address	904 Caribbean Drive Sunnyvale, CA 94089 USA
Website	www.cepheid.com/
Holding	No Holding Details

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International Regulatory Affairs

Job Summary:

The International Regulatory Affairs Specialist will develop submission strategy for international filings related to new product for new and/or ongoing cancer diagnostic test product. This individual will prepare the appropriate regulatory submissions and interact with health authorities to obtain and maintain product approvals in
the EU and ROW as applicable. This position is temporary and part-time. The estimated duration is 12 months in length.

Responsibilities:

    *
      Responsible for updating and generation of EU technical files
    * Responsible for generating and delivering documentation for registration of Cepheid products into Latin America and Asia
    * Interact with global regulatory leaders in order to expedite approval of pending registrations
    * Partner with global and regional marketing in the development of regulatory plans
    * Manage and monitor multiple complex, novel, and/or diverse projects simultaneously, including projects that involve several functional areas
    * Maintain a "focused urgency" as required by specific events
    * Prepare formal written reports/documents for distribution within work unit and regions

Required Knowledge - Skills - and Abilities:

    * Bachelor’s 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
    * Sound basis of Regulatory and /or Scientific knowledge
    * Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
    * Domestic and international submissions experience is preferred
    * Previously created an EU Technical File
    * Have experience working with Design Dossier and CE Marking
    * Medical device experience is required. IVD product experience is highly preferred
    * 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

Other Job Information

Vacancy type:	Full Time	Contact Mode:	not provided
Fax:	+1-408-541-4192	Contact Name:	not provided
Job Duration:	not provided	Phone:	+1-408-541-4191
Email:	not provided