Regulatory Affairs Specialist

Organization
Cepheid - US
Job Location
Sunnyvale, CA 94089
Job Description

The Regulatory Affairs Specialist will prepare the regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals with a focus on China and Japan. Assist with ROW submissions as required. Participate in international regulatory intelligence groups and represent Regulatory Affairs on the product life-cycle management teams as needed.

 

  • Generate regulatory reports to communicate worldwide 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
  • 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
  • Assess potential impact and/or applicability to other related areas
  • Assess corrective action to assure it prevents recurrence
  • Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions
  • Provide regulatory training to cross-functional groups
  • 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 5 years of direct related experience in regulatory within an IVD or medical device manufacturing site
  • 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 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

 

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