Assistant Manager Quality and Regulatory

Who Are We

What We Want You To Do

• Execute required activities as part of ISO 27001 and ISO 62304 compliance
• Create, revise, and maintain relevant policies and procedures.
• Provide support for internal and external compliance audits.
• Perform periodic assessments and risk evaluations.
• Undertake activities relating to regulatory submissions for software as a medical device
  

Requirements

• The candidate must have the ability to execute tasks and document information
  

• Have an understanding of medical devices, quality assurance and quality checks
• Awareness of ISO 27001 and ISO 62304.
• Internal auditor certification for ISO 27001 and ISO 62304 is preferable.
• An understanding of regulatory pathways is preferable.
  

Skills

• Keen attention to details.
• Ability to critically evaluate scientific literature and integrate information from multiple
  

• Ability to work independently with minimal supervision as well as collaboratively in a
  

• Excellent organizational and time management skills with the ability to prioritize tasks
  

• Strong interpersonal and communication skills with the ability to interact professionally