Cepheid International Regulatory Affairs Manager in Moscow, Russia
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The International Regulatory Affairs Manager will prepare and manage the regulatory submissions for Cepheid products, oversee in country clinical trials and interact with regulatory agencies/health authorities in Russia and Eurasian countries to obtain and maintain product approvals.
· Generate regulatory reports to communicate registration activities
· Establish and review Regulatory Affairs priorities as they relate to department and company goals and objectives
· Interact with global 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
· Stays abreast of IVD regulations and guidances, especially those relevant to in vitro Diagnostics
· Maintain a "focused urgency" as required
· 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
· Provide regulatory training to cross-functional groups
· Provide support to Post-marketing activities
· Bachelor’s degree in a Life Science or related field preferred. Or, equivalent combination of education and experience to perform at this level
· A minimum of 4-5 years of related experience in regulatory within an IVD or medical device manufacturing site.
· A minimum of 2-3 years of Managerial experience.
· Sound basis of Regulatory and /or Scientific knowledge
· Strong PowerPoint, Excel and Word knowledge
· Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
· 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
· 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
· IVD product experience is highly preferred
· International submissions experience is preferred
· Ability to communicate in Russian is required as well as being fluent in English
Cepheid is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Over a decade ago, Cepheid set the standard for innovation in automated molecular diagnostics with our first system and we’ve never looked back. And now, even with the largest installed base of any molecular platform, Cepheid is constantly innovating and evolving our capabilities. Our technology has been heralded as game-changing by healthcare leaders world-wide. We envision a better way for clinical institutions of any size, from small medical clinics to high-volume reference laboratories and major hospitals, to access the power of molecular diagnostics. Our GeneXpert® System delivers fast, scalable, and accurate diagnostic results while our expanding Xpert® test menu spans multiple clinical applications such as healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology. Make a difference in healthcare and join us on this mission! For more details, please visit us at www.cepheid.com at http://www.cepheid.com/us/ .