*Product: Medical device
*Headquarter role; managing area: TW& China
Ensuring company complies with all QMS and product-related regulations. Preparing submissions of QMS and product licenses and renewals to strict deadlines.
Monitoring and setting timelines for QMS and product licenses and renewal approvals.
Keeping up with international medical device legislation, guidelines and customer practices in all countries that the company is exporting to.
Undertaking and managing regulatory inspections.
Liaising with, and making presentation to regulatory authorities.
Partner with engineers on device license approvals.
Work with sales & marketing on product position and marketing claims.
Reviewing company practices and providing advice on changes to QMS.