MedTech Regulatory & QA Lead

EYRIS PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A medical technology firm in Singapore is seeking an experienced Regulatory Affairs and Quality Assurance Specialist. The role involves managing quality assurance objectives, authoring technical documents for medical devices, and conducting software testing. The ideal candidate has at least 2 years of relevant experience and strong communication skills, with a Bachelor's degree in IT or healthcare-related fields. This position is crucial for ensuring compliance and facilitating product commercialization.

Qualifications

• Minimum of 2 years' experience in Regulatory Affairs/Quality Assurance role.
• Relevant hands-on experience in software performance testing and functional testing for web applications.
• Excellent communication skills for cross-functional collaboration.
• Detail-oriented with good organizational skills.

Responsibilities

• Assist in authoring and reviewing technical documents for medical devices.
• Manage quality assurance team to achieve company quality objectives.
• Prepare technical dossiers for new device registrations.
• Conduct internal and external audits and risk management reviews.
• Evaluate customer feedback and perform quality assurance investigations.

Skills

Regulatory Affairs

Quality Assurance

Software Performance Testing

Functional Testing for Web Applications

Excellent Communication Skills

Detail Oriented

Organizational Skills

Education

Bachelor’s Degree in Information Technology or Healthcare

Job description

A medical technology firm in Singapore is seeking an experienced Regulatory Affairs and Quality Assurance Specialist. The role involves managing quality assurance objectives, authoring technical documents for medical devices, and conducting software testing. The ideal candidate has at least 2 years of relevant experience and strong communication skills, with a Bachelor's degree in IT or healthcare-related fields. This position is crucial for ensuring compliance and facilitating product commercialization.