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Our mission is to make the world a safer, more secure and sustainable place.
The Role
Support preparation and submission of medical device registration, renewals, and amendments; perform documentation review and gap analyses; research regulatory requirements; draft regulatory reports and quality procedures; respond to registrar or audit issues; support consulting project teams and liaise with local regulatory authorities as needed.
Summary Generated by Built In
JOB DESCRIPTION
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
When you combine the gravitas of a 130-year-old safety science leader with a culture of innovation that pushes the boundaries in new services and technology, you get UL Solutions. As a global team of business and engineering experts, we develop software for a huge range of industries, including medical, sustainability, renewable energy and healthy buildings. Together, we're dedicated to making a real-world difference, to using our knowledge for good and to pioneering positive change. Join our team and use your expertise to transform global safety, security and sustainability.
- Assist consulting team and clients with the preparation and submission of medical device registration/licensing applications to a single or specific number of regulatory markets.
- Prepare renewals or amendments to the above, and act as support to a project team lead (project manager or consultant); this may include direct client interaction which should be well documented.
- Develop and leverage knowledge of requirements and expectations for medical device submissions, understand the registration process, including whether tasks should be completed in parallel or sequentially and clearly delineate each process/phase to clients.
- Assist with client documentation review, gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements.
- Assist with or redirect internal or external inquiries related to quoting project hours and scope, including potential grouping or classification as applicable.
- Escalate complex regulatory issues identified by team or clients to senior experts as appropriate and follow through to resolution.
- Prepare regulatory reports.
- Perform activities such as: - Research on regulatory issues, involving web searches, review of internal library and other means - Summarizing technical and regulatory information in a written form - Serve as Lead Consultant on multi-market research projects as needed - Handle client inquiries and provide consultation regarding medical device quality assurance and regulatory compliance issues, such as: - Drafting / reviewing mandatory or operating procedures needed for quality assurance or regulatory compliance - Reviewing product labeling - Responses to issues arising from registrar or regulatory inspections / audits.
- Act as regulatory support on larger consulting project teams comprised of multiple stakeholders, including senior consultants, business development and project management.
- Where appropriate, act as initial liaison with local regulatory authorities on behalf of clients.
- Support Consulting team with RA and QA priorities as needed. Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices.
QUALIFICATIONS
- Bachelors' degree, preferably in a Medical, Engineering or Science field.
- Advanced, professional-level written and verbal English and excellent communication skills.
- Generally, 2-5 years of Quality Assurance and/or Regulatory Affairs experience working in the medical device field, in a regulatory, submissions or quality support role.
- Consulting experience a plus.
- Excellent attention to detail, research or device registrations experience a plus..
- Proficiency with Microsoft Office software.
- Strong multitasking, organization and prioritization skills.
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
When you combine the gravitas of a 130-year-old safety science leader with a culture of innovation that pushes the boundaries in new services and technology, you get UL Solutions. As a global team of business and engineering experts, we develop software for a huge range of industries, including medical, sustainability, renewable energy and healthy buildings. Together, we're dedicated to making a real-world difference, to using our knowledge for good and to pioneering positive change. Join our team and use your expertise to transform global safety, security and sustainability.
Skills Required
- Bachelor's degree (preferably Medical, Engineering, or Science)
- 2-5 years Quality Assurance and/or Regulatory Affairs experience in the medical device field
- Advanced professional-level written and verbal English and excellent communication skills
- Proficiency with Microsoft Office software
- Strong multitasking, organization and prioritization skills
- Consulting experience
- Attention to detail, research skills or device registrations experience
What the Team is Saying
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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
