Website jobsavant Medical Device Consulting Company

Help bring medical devices to market!

SUMMARY OF FUNCTIONS:

  • Assist with the creation of as well as create regulatory affairs and quality assurance deliverables for company clients

 

MAJOR DUTIES AND RESPONSIBILITIES:

  • Assisting with the development, authoring or implementation of
    • Regulatory Roadmaps and Assessments
    • Regulatory or Quality Assurance Gap Assessments
    • Cybersecurity Gap Assessments
    • IEC 62304 Gap Assessments
    • Quality Management Systems (QMS) and QMS components in compliance with US FDA and Global Quality System Regulations
    • Risk files and risk assessments
    • Software Development Lifecycle documentation
    • Documentation, protocols and data analysis for Usability Studies or Human Factors and Human Engineering Studies
    • Internal and supplier audits for compliance with Medical Device Quality System Regulations
    • Verification and Validation activities for medical devices
    • Medical Device or Combination Product submissions for clearance or approval for US or global medical device markets

ORGANIZATIONAL RELATIONSHIPS:

  • This person will directly work with Regulatory and Quality in support of customer projects.

EXPERIENCE AND/OR EDUCATIONAL REQUIREMENTS:

  • Minimum a Bachelor’s Degree in Computer or Electrical Engineering with a concentration in Computer Science.
  • Ability to proactively seek out and leverage resources responsibly
  • Understanding of Software Development Lifecycle and the duties of software developers
  • General understanding of Software Architectural principles
  • Ability to demonstrate effective verbal and writing skills.

To apply for this job please visit www.avant.jobs.