Job Description

Bioptimal International Pte. Ltd. (Formerly Biosensors International Pte Ltd) was founded in 1989.Focusing on the field of critical care medical devices for more than 30 years, we have rich experience in production and R & D. The company continues to develop thermodilution catheter, pressure monitoring system Biotrans*/ Accurans*/ Catrans, central venous catheter, embolectomy catheter, bipolar pacing catheter, silicone Foley catheter and other products. With its mature technology and excellent quality, the company has reached the first level in the world and obtained CE and FDA certification in many countries andregions. Its products are sold to more than 70 countries and regions in Asia Pacific, Europe, America and Latin America, but also for the world-class brands to provide OEM service.Through continuous innovation and optimization, we aim to provide the best service for customers, provide the best medical products for patients, and develop friendly with the environment for the benefit of human health.To provide the support in daily operations of Quality Assurance & Regulatory Affairs (QARA) processed through the following: * Drafting of procedures, work instructions and analysis reports in accordance with quality systems and regulations requirements.

• Post-market surveillance research and drafting of reports related to BPI products.
• Registration of the Unique Device Identifier (UDI) in regulatory platforms worldwide where our products are currently marketed.
• Perform administrative functions in areas related to:
• Communication to manufacturing facility on requested documents.
• Compiling and review of those requested documents to support QA and RA activities.
• Follow-up on documents approval.
• Maintenance of different QARA Masterlists (data entry job).
• Ad hoc and routine duties requiring support.

Application InstructionsPlease apply for this position by submitting your text CV using InternSG. or email to
Kindly note that only shortlisted candidates will be notified.

InternSG