Senior Regulatory Affairs Specialist - Instrument and Software

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

The Senior Regulatory Affairs Specialist provides guidance to project teams during design and development of software and instrumentation products and prepares related documentation for global regulatory submissions. Provides regulatory guidance for system integrations. Performs regulatory reviews for proposed software and instrumentation changes to determine impact on existing registrations. Monitors regulations, guidances and standards pertaining to IVD instrumentation and software. and informs affected groups of needed changes.

 

  • Responsible for generation and maintenance of software and instrumentation regulatory files
  • Responsible for generating and delivering documentation for registration of Cepheid software and instrumentation
  • 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 for software and instrumentation
  • 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
  • Informs affected groups of new and revised regulations, guidances and standards for software and instrumentation that require changes in documentation.
  • Formulates short-term planning for individual deliverables and participates in long term planning within the unit
  • Prepares formal written reports/documents for distribution within work unit and regions
  • Provides training or presentations on software and instrumentation to cross-functional groups

 

 

  • Bachelor’s degree in a scientific or engineering discipline, or equivalent combination of education and experience to perform at this level
  • A minimum of 8 years experience with medical device software and instrumentation.
  • Sound basis of Regulatory, Quality and applicable Engineering knowledge, including safety and EMC requirements
  • Demonstrates in-depth understanding of advanced engineering/scientific principles that relate to documentation requirements for medical device registrations.
  • Domestic submissions with 510(k). PMA experience a plus
  • Have experience working with instrument and software Design Dossiers for global registrations, including CE Marking
  • Medical device experience is required
  • Ability to interpret subjective and complex aspects of standards, regulations and guidances specific to medical device software and instrumentation
  • 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 information
  • Ability to work in a self-directed manner to see issues through to completion

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