- Provide proactive leadership of all RA issues;
- Lead company's product certification scheme;
- Drive product registration and/or marketing approval activities in accordance with requirements of FDA;
- Oversee all complaints and make the decision on necessary actions, including if a complaint needs to be reported;
- Follow up FDA regulatory requirements;
- Interpret FDA regulations and regulatory requirements to ensure product compliance;
- Provide company with support and guidance on medical device regulations;
- Perform associated and other duties as required.
- Bachelor degree or above in biomedical engineering or medical image engineering;
- 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);
- Familiar with registration policies, regulations and standards of medical device product (preferred);
- Good communication skills with internal and external parties;
- Team player with strong interpersonal skills;
- Learning ability and logical thinking ability;
- Good working attitude and working passion;
- Good reading and writing skills.
Apply below or email your resume to Career_US@united-imaging.com including the job title and location.