RA Director

Responsibilities

1. Responsible for the research and transformation of domestic and foreign medical device registration technical standards, and responsible for the entire process of product pipeline registration;
2. Lead the work related to the approval of innovative medical devices
3. Responsible for organizing expert consultation meetings and evaluation meetings
4. Responsible for the testing/inspection work related to the company’s product registration
5. Organizing and coordinating the registration-related work such as quality system and clinical trials

Requirements

1. Possess a doctoral degree in bioengineering, chemistry, polymer materials and other related majors
2. More than two years of relevant work experience in three types of implanted medical devices (such as cardiac stents/pacemakers/vascular stents/orthopedic implant products, etc.)
3. Familiar with domestic and EU, FDA, ASEAN, Japan, Canada and other major international regional medical device registration procedures
4. Familiar with relevant regulations and standards for medical devices, and have good writing skills in both Chinese and English