Job Description

Date: 07-Jul-2022 Location: Kent Ridge Campus, SG Company: National University of Singapore

The Director of Operations will be responsible for planning and execution of a complete and effective quality management system (QMS). This will be to ensure a preparedness for upcoming Breakthrough Device Designation application and subsequent FDA approval for initial Class 3 medical device (Singvalve) and subsequently applications for Endopsis and Aulus devices. The Director of Operations role will also include project planning, project management and product development. The sourcing and development of a core team, sourcing and development of certified vendors and the sourcing and development of manufacturing partners. The Director of operations will develop and execute a business and operational plan, manage financial requirements and budgets and oversee the set up, construction, qualification and operations of an ISO7/10k cleanroom.

Qualifications

• Minimum 15 years medical device experience in both class 3 and class 2 products. Must have surgical valve experience
• Knowledge of product design development/design verification as well as product transfes of class 3 medical devices
• Experienced in FDA/ISO requirements with a track record of successfully establishing QMS systems as well as successfully completing related on-site audits
• Program/project management for start-up organizations within Asia region; as well as assuming leadership roles in multiple regional locations i.e. (also EU/USA) is preferred
• Senior sales/marketing background with a focus on GTM solution development and multi country sales force team development and management
• Prior cost accounting experience as well as factory application is a must
• Experience in project managing factory and class 10,000 clean room build out projects
• Prior plant/factory head experience in Class 3 medical device
• Prior experience as a consultant and or manager of a team consisting of several contributing consultants

Covid-19 Message

At NUS, the health and safety of our staff and students are one of our utmost priorities, and COVID-vaccination supports our commitment to ensure the safety of our community and to make NUS as safe and welcoming as possible. Many of our roles require a significant amount of physical interactions with students/staff/public members. Even for job roles that may be performed remotely, there will be instances where on-campus presence is required. Taking into consideration the health and well-being of our staff and students and to better protect everyone in the campus, applicants are strongly encouraged to have themselves fully COVID-19 vaccinated to secure successful employment with NUS.

More Information

Location: Kent Ridge Campus Organization: Yong Loo Lin School of Medicine Department : Surgery Employee Referral Eligible: No Job requisition ID : 16388