Office hours: Mon-Fri, 830am to 530pm 
Office location: Marsiling, Singapore (8-10 mins walk from Woodlands MRT / bus interchange) 
Reporting into: Director, Legal Counsel, SEA 


Job Description:

• Registration of products per regulations and communication with government officials.
• Build rapport with regulatory agencies and notified bodies as required, to perform effective and fast approvals for product registrations.
• Product review to classify the medical devices & non-medical devices.
• Responsible for the daily imports/exports & co-ordinates all related custom clearance procedures, and ensure the company is in adherence to trade & regulatory compliance.
• Ensure the business compliance with regional / global regulations / requirements; such as FDA, HSA, CE IVD.
• In-charge with the timely approval renewal and maintenance of product licenses, company licenses, pre-and-post approval variations, permits and other applications.
• Monitor the regulatory development and trends in the region and report impact to the organization.
• Prepare site for government/regulatory audits and inspections.
• Site Quality Management System support – audits, review and update of regulatory SOPs, complaints, investigation, documentation review, approval and release, involve in Post market surveillance, risk management.
• Support regulatory requirements on sales of chemical products.

Requirements

• A Degree in Life Sciences, Pharmacy or related field
• 4-8 years’ RAQA experience - medical device (IVD) field is preferred
• Able to work, under pressure and flexible working hours based on business requirements for conference calls, etc.
• Good communications skills with ability to interact and collaborate with cross functional business units.
• Analytical and detail oriented

• Malaysia country RAQA experience on top of Singapore country experience 
• Chemical industry experience and related licenses like Dangerous Goods handling, etc.