• Job Description

  Req#: GwMbH80jX4qy
  Employer Industry: Medical Device Regulatory Consulting
  
  Why consider this job opportunity:
  - Competitive salary with comprehensive benefits package
  - 100% employer-paid health insurance premiums
  - Opportunity for career advancement and professional development
  - Work remotely from anywhere within the continental U.S.
  - Supportive and collaborative work environment
  - Chance to contribute to innovative AI solutions for U.S. regulatory processes
  
  What to Expect (Job Responsibilities):
  - Serve as a liaison between AI leadership for medical devices and Data Science teams
  - Draft, present, and track activities related to business requirements and feature integration
  - Facilitate the development of working prototypes or minimum viable products (MVPs) for FDA applications
  - Assess the effectiveness of tools impacting the FDA's regulatory review processes
  - Coordinate day-to-day project activities and maintain effective communication with stakeholders
  
  What is Required (Qualifications):
  - Bachelor’s degree or higher in Data Science, Biomedical Engineering, Computer Science, or a related field
  - Minimum of 5-7 years of experience as a Business Analyst
  - Prior experience in pre-market regulatory review processes within the medical device industry, preferably with the FDA
  - Solid proficiency with SQL for data querying and analysis
  - Ability to obtain and maintain a Public Trust clearance
  
  How to Stand Out (Preferred Qualifications):
  - Familiarity with Agile development methodologies and tools
  - Experience with wireframing tools for user interface and interaction design
  - Excellent oral and written communication skills, particularly in creating presentations
  - Strong customer service and collaboration skills
  - Exceptional analytical and critical thinking abilities
  
  #MedicalDevices #RegulatoryConsulting #AI #RemoteWork #CareerGrowth

• About the company

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