Regulatory Affairs Specialist - Medical Devices

About the role

UIH Technologies L.L.C. is the Houston-based manufacturing organization for Shanghai United Imaging Healthcare Co., Ltd. in North America. It is a start-up introducing a new portfolio of innovative imaging products to the USA market, with its first employees joining in Q4 2018. The company seeks a Regulatory Affairs professional to lead regulatory matters for its medical device products.

Key responsibilities

• Provide proactive leadership of all regulatory affairs issues
• Lead the company's product certification scheme
• Drive product registration and/or marketing approval in line with FDA requirements
• Oversee complaints and decide on necessary actions, including whether a complaint must be reported
• Follow up FDA regulatory requirements and interpret them to ensure product compliance
• Support the company with guidance on medical device regulations
• Perform other associated duties as required

Required profile

• Bachelor's degree or above in biomedical engineering or medical image engineering
• 2 years of relevant experience as a registered engineer or regulatory engineer for active medical devices (preferred)
• Familiarity with medical device registration policies, regulations and standards (preferred)
• Good communication, teamwork and interpersonal skills
• Learning ability, logical thinking, good reading and writing skills