Head Of Safety, Quality & Regulatory- Oral Health Care

Philips UK

Fully remote
15+ years experience in product design quality
Iso 13485 medical device expertise
Iso 9001 quality management systems
The role is accountable for overseeing product, hardware, and software quality, risk management, and regulatory activities throughout the entire product life cycle

Job Summary

  • The role is accountable for overseeing product, hardware, and software quality, risk management, and regulatory activities throughout the entire product life cycle.
  • Candidates must have extensive experience in both ISO 13485 and ISO 9001 standards with a proven track record in FDA Class I medical device design.
  • Philips is a global health technology company dedicated to improving lives through access to quality healthcare.

Matching Summary

Match Score: 85

The role is accountable for overseeing product, hardware, and software quality, risk management, and regulatory activities throughout the entire product life cycle.

Skills & Requirements

Must-have

  • 15+ years experience in Product Design Quality
  • ISO 13485 Medical Device expertise
  • ISO 9001 Quality Management Systems
  • FDA Class I medical device design experience
  • Risk Management FMEA ISO 14971 proficiency
  • Biocompatibility ISO10993-1 knowledge
  • Team leadership and succession planning

Nice-to-have

  • Advanced statistics capabilities
  • Consumer goods and cosmetics background
  • Continuous improvement culture promotion
  • Strategic business development collaboration
  • Global team management across time zones

Key Requirements

  • Minimum 15+ years experience
  • Bachelor's Degree in Quality or Engineering
  • Experience with Hazardous Substance Management
  • Post Market Surveillance integration skills

Work Rights

Not specified

Tailored Resume

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