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
- 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.