Quality Manager/Senior Quality Manager

BALANCE MEDICAL HOLDINGS (SG) PTE. LTD.

Singapore, Singapore
Not specified
Iso 13485 compliance implementation
Eu mdr2017/745 regulatory knowledge
Fda 21 cfr part 820 qmsr expertise
BALANCE MEDICAL HOLDINGS is seeking a Quality Manager/Senior Quality Manager to oversee the Quality Management System and regulatory affairs for Class III implantable medical devices, ensuring compliance with relevant regulations. The ideal candidate will have extensive experience in quality assurance and regulatory submissions in the medical device industry, along with strong leadership skills

Job Summary

  • The role is responsible for establishing and maintaining a robust Quality Management System compliant with ISO 13485, EU MDR, and FDA regulations.
  • Candidates will lead regulatory strategies and inspections for CE marking and FDA approval of Class III implantable medical devices.
  • This position requires driving quality engineering initiatives including process validation, risk management, and continuous improvement within a cross-functional team.

Matching Summary

Match Score: 85

BALANCE MEDICAL HOLDINGS is seeking a Quality Manager/Senior Quality Manager to oversee the Quality Management System and regulatory affairs for Class III implantable medical devices, ensuring compliance with relevant regulations. The ideal candidate will have extensive experience in quality assurance and regulatory submissions in the medical device industry, along with strong leadership skills.

Skills & Requirements

Must-have

  • ISO 13485 compliance implementation
  • EU MDR2017/745 regulatory knowledge
  • FDA 21 CFR Part 820 QMSR expertise
  • Class III implantable device experience
  • Regulatory submission leadership
  • CAPA and internal audit oversight

Nice-to-have

  • ISO 14644 cleanroom familiarity
  • ISO 10993 biocompatibility standards
  • ISO 5840 heart valve standards
  • Start-up greenfield environment experience
  • Strategic mindset with execution capability
  • Cross-functional stakeholder management

Key Requirements

  • Bachelor's degree in Biomedical Engineering or related field
  • Minimum 10 years industry experience
  • At least 5 years in leadership capacity
  • Proven experience with Class III device submissions

Work Rights

Not specified

Tailored Resume

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