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Job Title
HEAD OF REGULATORY AND COMPLIANCE, US

DESCRIPTION

We are looking for an regulatory and compliance leader that will help us deliver our world-class digital platform that delights our customers and positively impacts the surgical landscape, empowering surgical communities worldwide. You’ll work both across the entire company and also across regions and surgical disciplines to ensure the regulatory compliance, and data strategy delivers on what’s best for the surgeon, the patient, and our business partners.

REQUIREMENTS AND RESPONSIBILITIES:

  • Understand the regional regulatory and data landscape and define regulatory strategy.
  • Manage regulatory submissions worldwide, particularly in the US and EU
  • Evolve the quality management system to meet Proximie’s growing needs and expanding product portfolio
  • Manage global data legal outside counsel teams to deliver the Proximie platform worldwid
  • Perform role of Data Protection Officer under GDPR and equivalent roll in other regions, or assign responsibility appropriately and provide oversigh
  • Provision of education and support to the operations team in relation to data privacy and hospital deployment cycle
  • Work with the operations team to ensure hospital (data related) contracting is completed correctly and remains up to date as the product / regulations evolve
  • Responsibility for defining internal data privacy-related policies & procedures and monitoring compliance.

REQUIRED SKILLS:

  • BA/BS in Biomedical Engineering or related field
  • 10+ years of medical device, Medtech, and digital health experience
  • Track record of delivering exceptional, compliant regulated products to market
  • 3+ years experience with global data privacy strategy
  • 2+ years experience building out and managing quality management systems, ISO13485, etc.
  • Good communicator with the ability to align across many stakeholder groups
  • Knowledge of data privacy laws (especially GDPR, HIPAA)

DESIRED SKILLS:

  • Knowledge of data privacy laws (especially GDPR, HIPAA)
  • Start-up and/or healthcare experience
  • MS in Biomedical Engineering, Computer Science, Electrical Engineering or related technical field
  • Experience with Health IT, Digital Health and/or surgical domain

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