Regulatory Affairs Executive/Senior

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

Essential Duties and Responsibilities:

Regulatory Affairs Responsibilities:

• Assist in authoring, editing and reviewing of technical documents e.g. medical device verification & validation documents, standard operating procedures, risk management plans and reports for medical devices.
• Assist in the preparation, review and compilation of technical dossiers for the purpose of new device registrations and submission of change notifications to regulatory bodies.
• Provide key regulatory inputs to business development team to assist in achieving the company’s overall business objectives.
• Liaise closely and communicate effectively with key stakeholders on regulatory matters to aid in product commercialization.

Quality Assurance Responsibilities:

• Manage and lead quality assurance team on-site to achieve company quality assurance objectives.
• Responsible for the upkeep and implementation of the company’s Quality Management System (QMS) in accordance to international quality standards e.g. ISO 13485:2016
• Collaborate with on-site technical team to consolidate and review quality assurance data, conduct trend analysis and implement improvements to the company’s QMS.
• Plan and execute internal and external audits and risk management reviews according to international quality standards.
• Perform software quality assurance testing prior to medical device release.
• Evaluate and review customer feedback promptly, implement and conduct quality assurance investigations for product complaints and implement the necessary corrective and preventive actions.

Work Experience Requirements:

• A 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 are required as the incumbent is expected to participate in cross‑functional collaboration with different stakeholders.
• Detail oriented with good organizational skills.

Education Level Requirements:

• Bachelor’s Degree/Diploma in information technology/healthcare related discipline.