Quality & Regulatory Affairs Manager

OPH HEALTH PTE. LTD.

Singapore, Singapore
Not specified
Iso 13485 quality system implementation
Global medical device regulatory strategies
Hsa fda ce regulatory submission experience
OPH Health Pte. Ltd. is seeking a Quality & Regulatory Affairs Manager to oversee the implementation of quality systems and regulatory compliance for medical devices. The ideal candidate will have extensive experience with ISO 13485, global regulatory strategies, and supplier quality management

Job Summary

  • The role involves owning and executing quality and regulatory responsibilities across product delivery and global expansion.
  • Candidates must establish ISO 13485 systems and drive medical device registrations with HSA, FDA, and CE bodies.
  • The position requires acting as the quality owner for delivery issues, customer complaints, and supplier management.

Matching Summary

Match Score: 85

OPH Health Pte. Ltd. is seeking a Quality & Regulatory Affairs Manager to oversee the implementation of quality systems and regulatory compliance for medical devices. The ideal candidate will have extensive experience with ISO 13485, global regulatory strategies, and supplier quality management.

Skills & Requirements

Must-have

  • ISO 13485 quality system implementation
  • Global medical device regulatory strategies
  • HSA FDA CE regulatory submission experience
  • Supplier quality management and issue resolution

Nice-to-have

  • Strong execution mindset for end-to-end issues
  • Experience working with external consultants
  • Ability to manage cross-border teams effectively

Key Requirements

  • Hands-on experience with ISO 13485
  • Proven global medical device regulatory strategy experience
  • Practical experience in supplier quality management

Work Rights

Not specified

Tailored Resume

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