Daily Duties:

  • Lead projects focused on medical device governance, risk and compliance.
  • Hands on system selection, acquisition, specification, configuration, design assurance, implementation etc.
  • Technical evaluations of enterprise level (non-product) systems such as embedded devices, applications, middleware, databases, infrastructure and IT networks
  • Lead requirement elicitation and detailed design discussions across several business units (developers, analysts, R&D, quality/regulatory etc)

Must Have Requirements:

  • At least 5 years experience with Non-Product Software Validation
  • Experience with regulatory compliance or FDA regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971)
  • Experience with guidance such as NIST, IEC, GAMP, GDPR or Data Integrity
  • Experience designing and performing quality and compliance risk assessments
  • Experience with software development methods (SDLC)
  • Bachelors degree in engineering, science or a similar discipline
  • US Citizenship required

Additional Qualifications:

  • Experience working in a manufacturing, business or a laboratory environment
  • Knowledge of security-by-design, change management, contingency planning, disaster recovery
  • Certifications a plus: CISA, CRISC, CGEIT, CISSP, GSSP, CSSLP, SSCP, CPP, CSQE, CQA

Sthree US is acting as an Employment Business in relation to this vacancy.