Sr. Manager, Regulatory And Quality Affairs

Nordson Medical

Quality management system (qms)
Fda 21 cfr part 820
Iso 13485
The Senior Manager, Regulatory and Quality is responsible for leading the development, implementation, and continuous improvement of the Quality Management System (QMS) across all manufacturing and product development operations

Job Summary

  • The Senior Manager, Regulatory and Quality is responsible for leading the development, implementation, and continuous improvement of the Quality Management System (QMS) across all manufacturing and product development operations.
  • This role ensures compliance with FDA (21 CFR Part 820), ISO 13485, and EU MDR/CE requirements, while driving a culture of quality, operational excellence, and cross-functional collaboration.
  • Nordson MEDICAL is a global team that works to create components for life-saving medical devices.

Matching Summary

The Senior Manager, Regulatory and Quality is responsible for leading the development, implementation, and continuous improvement of the Quality Management System (QMS) across all manufacturing and product development operations.

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • FDA 21 CFR Part 820
  • ISO 13485
  • EU MDR/CE requirements
  • Risk-based quality systems
  • Design controls
  • CAPA
  • Risk management

Nice-to-have

  • Strategic quality leader
  • Solutions-oriented
  • Proactive culture
  • Engaging, visible leader
  • Cross-functional collaboration

Key Requirements

  • Bachelors degree in technical field
  • 12+ years experience in medical device industry
  • Experience with 21 CFR 820
  • Experience with ISO 13485:2003
  • Experience with EU Medical Device Directive
  • Experience with 510(k) Premarket Notification

Work Rights

Not specified

Tailored Resume

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