30 ott - Carugate
UL Solutions
Job Description
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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
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
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
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