Senior Knowledge Specialist, GMA

UL Solutions; Chicago (IL); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Annual bonus

Health/Dental/Vision insurance

401(k) retirement plan

Paid time off

Job summary

UL Solutions is seeking an experienced regulatory intelligence professional in Chicago to develop and maintain deep expertise in global medical device cybersecurity regulations, standards, and conformity assessment requirements.

You will monitor regulatory changes, interact with authorities, contribute to business growth, and lead research projects across regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East.

Qualifications

• Bachelor's degree in a relevant field.
• 5–7 years of relevant experience.
• Strong English communication.
• Ability to synthesize regulatory requirements.
• Experience with global medical device regulations.

Responsibilities

• Develop regulatory intelligence and research reports.
• Monitor changes across NA, EU, APAC, LATAM, ME.
• Explain regulatory requirements and pathways to customers.
• Lead training programs on medical cybersecurity requirements.
• Collaborate with BD teams to identify knowledge service opportunities.

Skills

Regulatory knowledge

Stakeholder engagement

Project management

Communication skills

Research & analysis

Leadership

Education

Bachelor's Degree in Engineering/CS/InfoSec

Biomedical Engineering

Information Security

Job description

Job Description

You are responsible for developing and maintaining deep expertise in global medical device cybersecurity regulations, standards, guidance documents, and conformity assessment requirements. The individual will monitor regulatory changes, interact with authorities and industry stakeholders, contributes to business growth initiatives, and lead complex research projects, represent GMA as a cybersecurity knowledge leader, and provide advisory support for customer engagements related to regulatory compliance and market access. The role drives the creation of regulatory intelligence content, customized research studies, training materials, customer-facing reports, and strategic insights covering cybersecurity requirements across regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East, etc. This position also contributes to the expansion of GMA knowledge services in cybersecurity, artificial intelligence, data governance, connected health technologies, software as a medical device (SaMD), and emerging digital health regulations. The individual is expected to build strong relationships with authorities, industry associations, and internal technical experts to strengthen UL's market leadership in medical cybersecurity services.

Responsibilities

• Demonstrate the ability to complete core daily tasks cross multiple regulations, countries, such as:
• Publishing high-quality news and delivering accurate and valuable research report with a high level of quality and within required timelines
• Maintaining data
• Updating relevant internal files trackers and related resources
• Develop and deliver internal and external training programs on medical cybersecurity requirements.
• Provide mentorship, coaching, and technical guidance to team members.
• Monitor and research global medical device cybersecurity regulations, guidance documents, standards, and industry best practices.
• Analyze regulatory frameworks such as:
  • FDA Cybersecurity Requirements for Medical Devices
  • EU Medical Device Regulation (MDR) cybersecurity expectations
  • ISO 14971 cybersecurity considerations
  • Cyber Resilience Act (CRA)
  • NIS2 Directive
  • AI Act cybersecurity requirements
  • FDA Premarket & Postmarket Cybersecurity Guidance
  • IMDRF Cybersecurity Frameworks
  • Health software and Software as a Medical Device (SaMD) requirements, etc.
• Explain regulatory requirements, certification pathways, and compliance expectations to customers and internal COUs and stakeholders.
• Collaborate with business development teams to identify knowledge service opportunities and support customer proposals.
• Assist in developing customized regulatory intelligence services and subscription offerings.
• Contribute to strategic expansion areas including cybersecurity, AI, data governance, and emerging technology regulations.
• Maintain accurate, current, and traceable regulatory content within GMA knowledge tools and databases.
• Develop executive summaries, impact assessments, and regulatory comparison reports.
• Provide point-of-access support to address any local acceptance issues under supervision and guidance.
• Support the CO team in identifying and investigating business opportunities related to emerging cybersecurity, data governance, and AI regulations.
• Read and follow the Underwriters Laboratories Code of Conduct, and follow all physical and digital security practices.
• Perform other duties as directed.

Qualifications

• Bachelor's Degree required.
• Minimum 5-7 years of relevant experience.
• Excellent working knowledge of the TIC business and the industries in which the business functions. Independently able to connect the regulation rules with customer needs and Business opportunities.
• Natural influencing skills, confidence and be able to deliver the message.
• Good planning, organization and project management skills. Earlier program management experience preferred.
• Able to deal in the ambiguity and take decisions, support customers in understanding their problem and provide valid solutions based on knowledge of schemes and past experiences.
• Experienced and knowledgeable for one or multiple geographic area, multiple areas of regulations and lead business decisions from COUs and other team members.
• Strong customer focus and solution-oriented mindset.
• Excellent in communication, able to summarize requirements and describe with easy word difficult concept, network builder.
• Excellent written and verbal communication skills in English.
• Bachelor’s Degree Engineering, Biomedical Engineering, Computer Science / Software Engineering, Medical Device Cybersecurity or Information Security or other specialization based on the specific coverage.

What We Offer

• The estimated salary range for this position is $90,000-$110,000 USD and is based on multiple factors, including job-related knowledge/skills, experience, geographical location, as well as other factors. This position is eligible for annual bonus compensation with a target payout of 10% of the base salary.
• This position also provides health benefits such as medical, dental and vision; wellness benefits such as mental and financial health; and retirement savings (401K) commensurate with the standard rewards offered in each individual location or country. We also provide full-time employees with paid time off including vacation (15 days), holiday and personal days (totaling 12 days) and sick time off (72 hours).

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. 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.

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