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The Biosensors International group of companies develop, manufacture and market innovative medical devices for interventional cardiology and critical care procedures. Our aim is to improve patients' lives through pioneering medical technology that pushes forward the boundaries of innovation. Read More
|Address||Blk 10, Kaki Bukit Avenue 1 #06-01/04 Kampong Ubi Industrial Estate Singapore 417942|
|Holding||No Holding Details|
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- Prepare and submit technical documentation for Critical Care product registrations/amendments/renewals in Asia Pacific, Europe, Japan, USA and Latin America.
- Familiarization of Design Control process to manage new product development and product design changes and maintain documentation.
- Responsible for the continuous Risk Management process for all Critical Care products and product-related activities to demonstrate product safety and efficacy.
- Perform Post Market Surveillance and ensure compliance with international requirements.
- Candidate must possess at least a Degree/Diploma in Life Sciences, Bioengineering, Biotechnology or any other related discipline; advantage for candidate with product registration experience.
- 1 – 2 years working knowledge and experience with registration authorities.
- Candidates with knowledge of ISO 13485, MDD 93/42/EEC, HSA regulations, FDA CFR Part 820, Canada Medical Device Regulations, Australian Medical Device Regulations will have an added advantage.
- Good command of English, both written and spoken.
- Self-motivated and able to work independently, with positive attitude and ability to approach challenges with fresh perspective
- Meticulous, Strong planning, interpersonal & organizational skills.
- Only Singaporean & SPR need apply.
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