Regulatory and Quality Assurance Medical Devices Technology Manager

Job Summary

A company is looking for a Regulatory and Quality Assurance Medical Devices Technology Manager.

Key Responsibilities:

• Lead the creation and ongoing review of QMS documentation
• Ensure software validation approach and associated documentation adhere to applicable medical device software regulations
• Manage, mentor, and develop a group of direct reports

Required Qualifications:

• Minimum of a degree in a science or engineering discipline
• 8 years Quality / Regulatory Assurance experience in a Pharmaceutical, Healthcare or Medical Device Industry
• Excellent understanding of Software Validation principles and a qualified or trained internal auditor
• Good understanding of 21CFR Part 11, Medical devices regulations and ICH-GCP requirements
• Prior experience with the verification and validation of software-based medical device products