Provide regulatory and quality assurance support for medical device clients: prepare and review MFDS and other submissions, identify compliance gaps, maintain QMS (KGMP, ISO 13485, QSR, MDSAP), perform audits, support premarket submissions and deficiency responses, and advise on labeling, clinical documentation, and marketing materials.
JOB DESCRIPTION
QUALIFICATIONS
OTHER DESIRED COMPETENCY AND QUALIFICATIONS:
ABOUT US
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.
ABOUT THE TEAM
We solve our customers' problems. Within Software & Advisory (S&A) services, UL Solutions' Product Lifecycle business helps our customers accelerate initial global market access and enhanced post-market longevity, and help achieve full lifecycle commercial compliance.
- Leveraging regulatory affairs expertise in the medical device industry to support clients with Quality Assurance and Regulatory compliance requests
- Preparing/reviewing local MFDS regulatory submissions and compiling technical documentation in line with applicable regulations
- Identifying compliance gaps and providing guidance for resolution
- Conducting research on regulatory requirements for the Korea markets and preparing peer-reviewed reports
- Supporting implementation and maintenance of Quality Management Systems (e.g., KGMP, ISO 13485, QSR, MDSAP)
- Performing internal and supplier audits for manufacturers, distributors, and vendors
- Reviewing regulatory documentation, preparing premarket submissions, and supporting deficiency responses from regulatory authorities
- Conducting literature reviews and preparing Clinical supporting documentation
- Advising on labeling, marketing materials, and website content from a regulatory perspective
- Adhering to Underwriters Laboratories ' Code of Conduct and security practices
QUALIFICATIONS
- Bachelor's degree in a relevant scientific discipline (e.g., Biomedical Engineering, Quality Engineering, Microbiology, Chemistry)
- Minimum 5 years of experience in Quality Assurance and Regulatory Affairs, ideally with some leadership exposure
- Strong understanding of global medical device regulations, particularly MFDS, KGMP, MDSAP countries, and/or the US
- Experience in preparing and reviewing technical documentation
- Familiarity with risk management processes (ISO 14971)
- Client-facing experience with strong interpersonal skills
- Fluency in English
OTHER DESIRED COMPETENCY AND QUALIFICATIONS:
- Undergrad or Postgraduate degree
- Lead auditor experience (QSR, ISO 13485, MDSAP)
- Experience with IVDs and/or device software / AI / SaMD
- Experience delivering training sessions
- Additional language proficiency
ABOUT US
A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers' product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers' products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.
ABOUT THE TEAM
We solve our customers' problems. Within Software & Advisory (S&A) services, UL Solutions' Product Lifecycle business helps our customers accelerate initial global market access and enhanced post-market longevity, and help achieve full lifecycle commercial compliance.
UL Solutions San Francisco, California, USA Office
San Francisco, CA, United States
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