Regulatory Affairs Associate / Senior Associate
Hansen Medical - Mountain View, CA

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Summary:
This position is responsible for regulatory product submissions and regulatory compliance activities. Develops and maintains domestic and international submissions. Reviews international and domestic labeling and product design documentation ensuring compliance with regulatory requirements. Provides regulatory guidance to cross-functional teams.
Essential Functions:

  • Prepares, submits and maintains domestic and international regulatory submissions
  • Participate in cross functional teams for development projects
  • Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval
  • Responsible for regulatory review & approval of non-conforming product
  • Provides regulatory guidance as needed
  • Develop and maintain regulatory procedures and policies to ensure ongoing compliance of existing and new products
  • Other duties as assigned

Requirements:

  • Bachelor’s Degree and minimum of 3-9 years related professional experience; equivalent combination of education and experience
  • Knowledge of current FDA regulatory requirements and trends for medical device Premarket Notifications
  • Knowledge of software, capital equipment and disposable product design practices
  • Experience with electro-mechanical and sterile disposable products. Familiar with product biocompatibility, sterilization and packaging requirements
  • Knowledge of ISO / MDD and Canadian regulatory requirements
  • Ability to influence and work with personnel at all levels and functional boundaries
  • Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.)
  • A self-starter with the ability to work independently and as part of a team
  • Good prioritizing, organization, interpersonal, communication and analytical skills
  • Good computer skills with knowledge of Microsoft Office

Hansen Medical, Inc. is an Equal Opportunity Employer.


Indeed - 11 months ago - save job - block
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