Regulatory Affairs

Houston, TX

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.

Apply below or email your resume to Career_US@united-imaging.com including the job title and location.

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