Regulatory Affairs & Quality Assurance Specialist

Location
3521 Leonard Ct, Santa Clara, CA 95054
Salary
Salary + bonus + benefits
Posted
Oct 16, 2021
Ref
for Yuan
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

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