Senior Manager, Regulatory And Quality Affairs

Nordson Medical

Florida, United States
Quality management system (qms) leadership
Fda 21 cfr part 820 compliance
Iso 13485 compliance
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.
  • Partner with R&D, Operations, and Regulatory teams to ensure quality considerations are integrated throughout the design, verification, validation, and clinical trial processes.
  • Lead and mentor a team of quality professionals, fostering a proactive, solutions-oriented, problem-solving, and compliance-driven culture.

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) leadership
  • FDA 21 CFR Part 820 compliance
  • ISO 13485 compliance
  • EU MDR/CE requirements
  • Risk-based quality systems
  • Design controls, CAPA, risk management

Nice-to-have

  • Strategic quality leader
  • Proactive, solutions-oriented culture
  • Engaging, visible leader
  • Cross-functional collaboration
  • Continuous improvement initiatives

Key Requirements

  • Bachelors degree in technical field
  • 7-10 years experience medical device industry
  • Experience with 21 CFR 820, ISO 13485
  • Experience with CE Marking
  • Experience with 510(k) Premarket Notification

Work Rights

Not specified

Tailored Resume

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