Senior Medical Device Cybersecurity Specialist – EU Regulations
h3Job Description /h3pYou 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. /ppYou 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. /ppThe 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. /ppThis 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. /ph3Responsibilities /h3pIn this role, you’ll help organizations navigate the evolving world of medical device cybersecurity, AI, and digital regulations. You’ll turn complex regulatory requirements into clear, practical insights for customers and internal teams. /pulliResearch and monitor global medical device cybersecurity regulations, standards, guidance, and industry trends. /liliPublish high-quality regulatory news, research reports, executive summaries,
impact assessments, and comparison reports. /liliProvide clear guidance on regulatory requirements, certification pathways, and compliance expectations. /liliDevelop and deliver internal and external training on medical device cybersecurity requirements. /liliBuild expertise across key regulations and frameworks, including: /liulliFDA medical device cybersecurity requirements and guidance /liliEU Medical Device Regulation (MDR) /liliCyber Resilience Act (CRA) /liliNIS2 Directive /liliEU AI Act /liliISO 14971 /liliIMDRF cybersecurity frameworks /liliHealth software and Software as a Medical Device (SaMD) requirements /li /ulliSupport customers and internal teams with regulatory questions and local market acceptance topics. /liliMentor and provide technical guidance to colleagues, sharing knowledge and best practices. /liliPartner with business development teams to identify new opportunities and support customer proposals. /liliHelp develop regulatory intelligence services and subscription-based knowledge offerings. /liliContribute to emerging areas such as cybersecurity, AI, data governance, and new technology regulations. /liliMaintain accurate and up-to-date regulatory information within internal knowledge tools, databases, and trackers. /liliFollow company standards for ethics, physical security, and digital security. /liliSupport other projects and responsibilities as needed. /li /ulh3Qualifications /h3ulliBachelor’s Degree Engineering, Biomedical Engineering, Computer Science / Software Engineering, Medical Device Cybersecurity or Information Security or other specialization based on the specific coverage. /liliMinimum 5-7 years of relevant experience. /liliExcellent 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. /liliNatural influencing skills, confidence and be able to deliver the message. /liliGood planning, organization and project management skills. Earlier program management experience preferred. /liliAble 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. /liliStrong customer focus and solution-oriented mindset. /liliExcellent in communication, able to summarize requirements and describe with easy word difficult concept, network builder. /liliExcellent written and verbal communication skills in English. /li /ulh3Total Rewards /h3pWe understand that rewards are an important consideration as you plan the next step in your career. The salary range for this position in Italy is 45000EUR to 55000EUR and is based on multiple factors, including job-related knowledge/skills, experience, geographical location, and other factors. This position is eligible for an annual premio with a target payout of 10 of base salary. You’ll also enjoy annual paid leave, access to our ULS University to support continuous learning and career growth, two volunteering days each year to participate in community activities, and flexible working arrangements designed to help you balance work and life. /ppDisclaimer: This role is gender-neutral and open to all qualified applicants, regardless of gender identity or expression /ph3About Us /h3pA 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. /p #J-18808-Ljbffr
impact assessments, and comparison reports. /liliProvide clear guidance on regulatory requirements, certification pathways, and compliance expectations. /liliDevelop and deliver internal and external training on medical device cybersecurity requirements. /liliBuild expertise across key regulations and frameworks, including: /liulliFDA medical device cybersecurity requirements and guidance /liliEU Medical Device Regulation (MDR) /liliCyber Resilience Act (CRA) /liliNIS2 Directive /liliEU AI Act /liliISO 14971 /liliIMDRF cybersecurity frameworks /liliHealth software and Software as a Medical Device (SaMD) requirements /li /ulliSupport customers and internal teams with regulatory questions and local market acceptance topics. /liliMentor and provide technical guidance to colleagues, sharing knowledge and best practices. /liliPartner with business development teams to identify new opportunities and support customer proposals. /liliHelp develop regulatory intelligence services and subscription-based knowledge offerings. /liliContribute to emerging areas such as cybersecurity, AI, data governance, and new technology regulations. /liliMaintain accurate and up-to-date regulatory information within internal knowledge tools, databases, and trackers. /liliFollow company standards for ethics, physical security, and digital security. /liliSupport other projects and responsibilities as needed. /li /ulh3Qualifications /h3ulliBachelor’s Degree Engineering, Biomedical Engineering, Computer Science / Software Engineering, Medical Device Cybersecurity or Information Security or other specialization based on the specific coverage. /liliMinimum 5-7 years of relevant experience. /liliExcellent 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. /liliNatural influencing skills, confidence and be able to deliver the message. /liliGood planning, organization and project management skills. Earlier program management experience preferred. /liliAble 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. /liliStrong customer focus and solution-oriented mindset. /liliExcellent in communication, able to summarize requirements and describe with easy word difficult concept, network builder. /liliExcellent written and verbal communication skills in English. /li /ulh3Total Rewards /h3pWe understand that rewards are an important consideration as you plan the next step in your career. The salary range for this position in Italy is 45000EUR to 55000EUR and is based on multiple factors, including job-related knowledge/skills, experience, geographical location, and other factors. This position is eligible for an annual premio with a target payout of 10 of base salary. You’ll also enjoy annual paid leave, access to our ULS University to support continuous learning and career growth, two volunteering days each year to participate in community activities, and flexible working arrangements designed to help you balance work and life. /ppDisclaimer: This role is gender-neutral and open to all qualified applicants, regardless of gender identity or expression /ph3About Us /h3pA 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. /p #J-18808-Ljbffr