UIH Technologies L.L.C. is the Houston-based manufacturing organization for Shanghai United Imaging Healthcare Co., Ltd. in the North America. We are building an organization of highly-motivated, team-oriented individuals to introduce a new portfolio of innovative imaging products to the USA market. We are a start-up organization that is building from the ground up with first employees coming on board in Q4 of 2018. United Imaging Healthcare develops and produces a full portfolio of advanced medical products covering the entire process of imaging diagnosis and treatment, and offers innovative medical IT solutions. The broad portfolio of innovative products has shown strong growth in China and other parts of Asia. It is our goal to build an organization of people committed to thinking creatively, and acting with the primary goal of delighting healthcare customers in the Americas region, while helping those customers to improve patient loyalty, quality of care and operational efficiency.

 
Main Responsibilities

1. Provide proactive leadership of all RA issues;

2. Lead company's product certification scheme;

3. Drive product registration and/or marketing approval activities in accordance with requirements of FDA;

4. Oversee all complaints and make the decision on necessary actions, including if a complaint needs to be reported;

5. Follow up FDA regulatory requirements;

6. Interpret FDA regulations and regulatory requirements to ensure product compliance;

7. Provide company with support and guidance on medical device regulations;

8. Perform associated and other duties as required.

 
Qualification Requirements

1. Bachelor degree or above in biomedical engineering or medical image engineering;

2. 2 year relevant working experience, working as a registered engineer or a regulatory engineer for active medical device products in a medical device company or a medical device agency company (preferred);

3. Familiar with registration policies, regulations and standards of medical device product (preferred);

4. Good communication skills with internal and external parties;

5. Team player with strong interpersonal skills;

6. Learning ability and logical thinking ability;

7. Good working attitude and working passion;

8. Good reading and writing skills.