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Our mission is to make the world a safer, more secure and sustainable place.
The Role
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.
Summary Generated by Built In
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.
Skills Required
- Bachelor's degree in a relevant scientific discipline (Biomedical Engineering, Quality Engineering, Microbiology, Chemistry)
- Minimum 5 years of experience in Quality Assurance and Regulatory Affairs
- Strong understanding of global medical device regulations, particularly MFDS, KGMP, MDSAP countries, and/or the US
- Experience preparing and reviewing technical documentation and regulatory submissions
- Familiarity with risk management processes (ISO 14971)
- Client-facing experience with strong interpersonal skills
- Fluency in English
- Leadership exposure or experience (preferred)
- Lead auditor experience (QSR, ISO 13485, MDSAP)
- Experience with IVDs and/or device software / AI / SaMD
- Experience delivering training sessions
- Additional language proficiency
What the Team is Saying
Jacqueline
Senior Software Sales Executive
Min
Software Product Manager
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Shubhankar
Sr. Data Scientist
Anthony
IT Technical Specialist
Emily
Software Solution Architect
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Ebony
Project Manager
Michael
Senior Director IT, Business Enablement
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UL Solutions Compensation & Benefits Highlights
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Strong & Reliable Incentives — Incentive pay is positioned as broad-based, with UL stating all employees are eligible for an annual performance bonus across regions. This universal design creates a consistent incentive foundation regardless of role or country.
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Retirement Support — Retirement offerings are described as strong, featuring a 401(k) with matching up to a total 5% and an additional 4% company retirement contribution after the first year in U.S. materials. Employees also reference access to an employee stock purchase plan in the U.S. and many major operating regions.
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Healthcare Strength — Health coverage breadth includes medical, dental, and vision with U.S. plans noting the company pays over 75% of medical premiums and offers PPO and HDHP options. Supportive programs like FSAs/HSAs, disability, life insurance, EAP, and mental‑health resources are frequently cited.
UL Solutions Insights
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The Company
What We Do
A global leader in applied safety science, UL Solutions transforms safety, security and sustainability challenges into opportunities for customers in more than 100 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 Certification Marks serve as a recognized symbol of trust in our customers’ products and reflect 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.
Why Work With Us
Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion and excellence.
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UL Solutions Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Depending on the role we offer hybrid or remote opportunities.
Typical time on-site:
Flexible
