Senior Regulatory Affairs Manager

Who are we?

UIH is a leading global medical device developer and supplier with a diversified portfolio of advanced imaging equipment and healthcare IT solutions. We are building an innovative team with the mission of developing and supplying advanced technologies and improving patient care worldwide. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The Regulatory Affairs Specialist will be responsible for establishing best practices in the area of pre- and post-market regulations, submissions and new product development.

Company Page: https://usa.united-imaging.com/

This position will require international travel and training for 2 weeks in Shanghai, China.

Responsibilities

• Provide proactive leadership of all RA issues.
• Lead company's product certification scheme.
• Drives establishment registration, device listing, and submits product reports via US-FDA Unified Registration and Listing System (FURLS).
• Supports the annual US-FDA sites registration and listing review and responds to RA information requests.
• Ensures marketing approval activities are in accordance with FDA requirements.
• Interprets FDA regulations and regulatory requirements to ensure product regulation compliance.
• Aware of and complies with the UIH Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position.
• Oversees complaint handling procedure.
• Provides company with support and guidance on medical device regulations.
• Maintains dashboards of activities and provides data for metrics.
• Performs other duties as required.