Regulatory Affairs & Quality Assurance Specialist

Micropoint Bioscience, Inc., a global provider of Point of Care (POC) testing systems and solutions, is seeking a highly motivated Regulatory Affairs and Quality Assurance Specialist to join its team in support of MBI’s diagnostic testing product pipelines.

Roles & Responsibilities

• Work with cross-function teams for product development and lifecycle management.
• Prepare application materials, reports and follow-up with Regulatory Agencies.
• Support QMS documentation, technical files/DHF.
• Support GMP facility maintenance/calibration schedule, Post Market Surveillance, CAPA Investigation.
• Other tasks as assigned

Qualifications

• A minimum of a Bachelor's degree in biology-related science, engineering, or other relevant disciplines with at least 5 years of regulatory affairs experience or applicable experience in a medical device development is required.
• Working knowledge of U.S. FDA medical device regulations and EU-IVDR is required.
• Experience in quality reporting, results validation, and industry quality guidelines is required.
• Proven track record clearing 510k medical devices to market in the US is a plus.
• Familiarity with international regulations and guidance in the medical device market including clearance/approvals of new devices and changes to devices (such as Europe, China, Brazil, Japan, etc.) a plus.
• Willingness and ability to work flexible schedules
• Mandarin proficiency is a plus