Senior Regulatory Affairs Specialist | GenomeWeb

Senior Regulatory Affairs Specialist

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

The Senior Regulatory Affairs Specialist performs the coordination and preparation of document packages for regulatory submissions from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. May direct interact with regulatory agencies on defined matters. Recommends strategies for earliest possible approvals of clinical trials applications.

  • * Responsible for generation and maintenance of regulatory files
  • * Responsible for generating and delivering documentation for registration of Cepheid products
  • * Interacts with global regulatory leaders in order to expedite approval of pending registrations
  • * Partners with global and regional marketing in the development of regulatory plans
  • * Establishes and reviews Regulatory Affairs priorities as they relate to department and company goals and objectives
  • * Manages and monitors 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
  • *
  • * Prepares formal written reports/documents for distribution within work unit and regions
  • * Provides training or presentations in multiple disciplines to cross-functional groups
  • * 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 8 years experience in a fast paced regulatory/compliance/quality team at a medical device manufacturing site
  • * 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
  • * Have experience working with Design Dossier and CE Marking
  • * Medical device experience is required
  • * 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/li>

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