Patient Safety & Quality Compliance Liaison

BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD.; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD. is seeking a qualified professional to manage product complaint events and assess patient safety impact across markets.

You will classify complaints, perform initial assessments, and coordinate with regulatory affairs and manufacturing to ensure compliance. The role requires strong documentation, data management, and the ability to translate complaint documents when needed.

Qualifications

• Minimum 3 years experiences in patient safety or relevant job roles.
• Bachelor in Nursing or Science or equivalent education/experience.
• Knowledge of EU guidelines and US FDA regulations is desirable.
• Understanding medical terminology and clinical assessment of adverse events in medical devices is desirable.
• Excellent oral and written communications with colleagues in Asian countries.
• Proficiency with Microsoft Office, including Excel.
• Ability to identify opportunities for continuous improvement.
• Excellent multi-tasking and prioritization under tight timelines.
• Responsible for safeguarding all information related to complaint handling.

Responsibilities

• Adhere to GDP across document management and ensure timeliness of complaint handling/assessment/reporting.
• Categorize product complaints using predefined criteria and obtain complete event information.
• Perform initial assessment of complaints considering medical knowledge and regulatory requirements.
• Communicate adverse events to line manager, regional regulatory affairs, and stakeholders.
• Translate foreign language complaint documents to English when necessary.
• Maintain complaint database/repository and follow up with stakeholders until closure.
• Manage complaint-related Return Goods Authorization.
• Prepare and present monthly complaint trending data to Quality/Manufacturing and monthly updates to the commercial team.
• Provide complaint and AE data for dossier/license renewal/PSR/PSUR/trend reports/recall.
• Act as backup to the line manager.
• Create/maintain SharePoint content for complaint handling; support ad hoc reports from departments; undertake ad hoc assignments.

Education

Bachelor in Nursing or Science

Tools

Microsoft Office Suite

Excel

Job description

BIOSENSORS INTERVENTIONAL TECHNOLOGIES PTE. LTD. is seeking a qualified professional to manage product complaint events and assess patient safety impact across markets.

You will classify complaints, perform initial assessments, and coordinate with regulatory affairs and manufacturing to ensure compliance. The role requires strong documentation, data management, and the ability to translate complaint documents when needed.