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.
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.
Bachelor’s degree in Engineering, Biological Sciences or equivalent focus.
Familiar with medical device registration, market access, federal regulations, compliance policies and standards.
A thorough understanding of 21 CFR 820, ISO 13485 and ISO9001.
6+ years relevant working experience, working in regulatory affairs for a medical device manufacturer or FDA regulated industry.
Previous experience with Class II / III Medical Devices (preferred)
Ability to communicate effectively in English (both written and oral).
Team player with strong interpersonal skills.
Learning ability and logical thinking ability.
Good working attitude and working passion.
Ability to understand technical documentation and execute associated procedures.
Fluent Chinese Mandarin speaker (preferred but not required).
Additional Salary Information: United Imaging Healthcare is unable to sponsor work visas at this time.
Internal Number: 1002
About United Imaging Healthcare
United Imaging (UIH) develops and produces a full portfolio of advanced medical imaging and radiotherapy equipment and offers medical IT and intelligent solutions. Founded in 2011 and headquartered in Shanghai, the company has subsidiaries and R&D centers across China, US, and other parts of the world. UIH’s vision is to lead healthcare innovation. Through innovation, UIH aims to contribute to bringing equal healthcare for all people worldwide.
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