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VP, Regulatory Affairs and Quality Assurance

3 months ago

Golden, Colorado, United States RapidAI Full time

RapidAI - Leading Innovation in AI for Healthcare

  • Empowering physicians to make faster decisions for better patient outcomes
  • Transforming care coordination with unparalleled patient visibility
  • Combining AI with patient care for revolutionary solutions

The VP RAQA will play a pivotal role in managing Quality and Regulatory activities to support iSchemaView's growth objectives, collaborating across various departments, such as Product Development, Marketing, and Legal. They will lead in enhancing the organization's capabilities to drive strategic initiatives.

Key Responsibilities:

  • Develop and implement regulatory affairs and quality assurance strategy & programs
  • Establish quality standards and metrics, and embed quality into the product development process
  • Build relationships with regulatory agencies and define regulatory strategies
  • Oversee global regulatory strategy to ensure compliance and alignment with corporate goals
  • Lead a culture of Quality across the organization

Requirements:

  • Bachelor's degree in relevant field; advanced degree preferred
  • Over 15 years of experience in leading RA/QA in life sciences
  • Extensive knowledge of US and global regulatory framework
  • Proven experience in regulatory submissions and engagements
  • Excellent communication and problem-solving skills
  • Demonstrated ability to manage multiple projects and teams effectively

What we offer:

  • Comprehensive medical, dental & vision coverage
  • Flexible spending accounts and 401k plan
  • Additional benefits like internet/cell/phone services coverage
  • Generous paid time off and holidays
  • Equity options, incentive compensation, and competitive salary ranges

RapidAI is committed to fostering an inclusive and diverse workplace, providing equal employment opportunities for all. We prioritize creating a supportive environment for our employees, promoting fairness and respect in all aspects of our operations.