Sep 24, 2021

Quality/Regulatory Engineer – SaMD

  • Elephas Bio
Full time Biotech

Job Description

Summary

Elephas, a Madison, WI-based biotechnology company, is seeking a highly motivated Quality/Regulatory Engineer with a focus on Software as a Medical Device (SaMD) to join our QA/RA team. A successful candidate will have a bachelor’s degree and be pursuing a career in Quality Assurance or Regulatory Affairs. This candidate will be self-motivated to learn and be comfortable in a fast-paced and highly collaborative environment. As a Quality/Regulatory Engineer at Elephas you will closely collaborate with a cross-functional team of Engineering, IT, and Product Management as you build and improve the Quality Management System (QMS).

 

Essential Duties and Responsibilities

  • This position is an integral member of the QA/RA team.
  • In this role, you will be responsible for ensuring documentation (e.g., DHF) and records within the QMS are complete and support development of software as/for/in a medical device application.
  • Drive requirements of the FDA Quality System Regulation 21 CFR Part 820, ISO 13485 Quality Management System - Medical Devices, and 2017/745 and 2017/746 EU MDR/IVDR.
  • Support product risk management activities for software (both pre-market and post-market)
  • Knowledge of FDA’s trend in AI/ML and Digital Health Center of Excellence
  • Provide support during inspections and audits, leading those related to software and AI/ML components.
  • Build and implement Quality procedures within the QMS for software and AI/ML components
  • Coordinate on regulatory and quality strategies and their execution, especially in support of software and AI/ML components
  • Have a commitment and passion for product compliance, quality, and safety.
  • Ability and desire to read, understand, and interpret regulations.
  • Be(come) a Quality Management System (eQMS) superuser
  • Support employee training activities
  • Investigate quality events using root cause analysis tools.
  • Perform other duties to support the QA/RA department as requested.

 

Education/Experience/Skills

  • Bachelor’s degree in life sciences, engineering, biotechnology, or related sciences preferred.
  • Experience working in QA/RA specifically in support of SaMD development and operations.
  • Experience with Software as a Medical Device (SaMD) and AI/ML
  • Knowledge of Software Quality Engineering fundamentals a plus
  • Strong understanding of Good Documentation Practices
  • Computer proficiency of Microsoft Office Suite
  • Excellent verbal, interpretation, and written communication skills

 

Benefits

  • Practical experience with varied business activities
  • Work, shadow, and train alongside accomplished professionals
  • Contribute to the formidable mission of Elephas
  • Competitive compensation

 

Qualified candidates should forward their resumes to Mindy Costin mcostin@elephasbio.com  


Apply Now