Sr. Design Quality and Regulatory Engineer

2 weeks ago


Singapore -310e-4e76-858d-a0537154b9f0 Full time $100,000 - $120,000 per year

Skills, experience & qualifications required:

  • Bachelor's degree in engineering discipline. Master's degree in engineering discipline preferred.
  • 5+ years in a quality or regulatory engineering role in the Medical Device field or highly regulated industry.
  • Minimum 3+ years in a quality or regulatory role with focus on Software.
  • Knowledge of and experience in IEC 62304 and experience with software design and validation for medical devices.
  • Knowledge of the standards related to medical devices, including ISO 13485, 21 CFR Part 820 and ISO 14971.
  • Understanding of design control, disciplined product development processes, regulatory, and quality requirements.
  • ISO 13485 inspections and FDA inspections experience preferred.

Job Types: Full-time, Permanent

Benefits:

  • Health insurance

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