Senior Medical Device Cybersecurity Specialist – EU Regulations

UL Solutions; Carugate; Hybrid; EUR 45,000 - 55,000; Full time

Benefits offered by this job

Annual bonus (target 10%)

Annual paid leave

ULS University access

Two volunteering days per year

Flexible working arrangements

Job summary

UL Solutions is seeking a senior regulatory intelligence specialist in Italy to develop deep expertise in global medical device cybersecurity regulations, standards, and conformity assessment requirements. The role leads regulatory research, content creation, and advisory support for customer engagements, with a focus on market access across regions including Europe, North America, and Asia-Pacific.

You will drive training, develop subscription knowledge services, and build strong relationships

Qualifications

• Bachelor’s Degree or higher in an engineering or related field.
• Minimum 5–7 years of relevant experience.
• Strong knowledge of TIC business and related industries.
• Ability to connect regulation with customer needs and opportunities.
• Excellent written and verbal communication in English.

Responsibilities

• Research and monitor global medical device cybersecurity regulations, standards, guidance, and industry trends.
• Publish high-quality regulatory news, research reports, and impact assessments.
• Provide guidance on regulatory requirements, certification pathways, and compliance expectations.
• Develop and deliver internal and external training on medical device cybersecurity requirements.
• Build expertise across key regulations and frameworks (FDA MDR CRA NIS2 EU AI Act ISO 14971 SaMD).
• Support customers and internal teams with regulatory questions and local market topics.
• Mentor colleagues and support business development with proposals.
• Maintain regulatory information in internal tools and trackers.

Skills

Regulatory knowledge

Communication skills

Project management

English proficiency

Customer focus

Ambiguity handling

Education

Bachelor’s Degree in Engineering

Biomedical Engineering

Computer Science / Software Engineering

Medical Device Cybersecurity

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.

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

In 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.

• Research and monitor global medical device cybersecurity regulations, standards, guidance, and industry trends.
• Publish high-quality regulatory news, research reports, executive summaries, impact assessments, and comparison reports.
• Provide clear guidance on regulatory requirements, certification pathways, and compliance expectations.
• Develop and deliver internal and external training on medical device cybersecurity requirements.
• Build expertise across key regulations and frameworks, including:
• FDA medical device cybersecurity requirements and guidance
• EU Medical Device Regulation (MDR)
• Cyber Resilience Act (CRA)
• NIS2 Directive
• EU AI Act
• ISO 14971
• IMDRF cybersecurity frameworks
• Health software and Software as a Medical Device (SaMD) requirements
• Support customers and internal teams with regulatory questions and local market acceptance topics.
• Mentor and provide technical guidance to colleagues, sharing knowledge and best practices.
• Partner with business development teams to identify new opportunities and support customer proposals.
• Help develop regulatory intelligence services and subscription-based knowledge offerings.
• Contribute to emerging areas such as cybersecurity, AI, data governance, and new technology regulations.
• Maintain accurate and up-to-date regulatory information within internal knowledge tools, databases, and trackers.
• Follow company standards for ethics, physical security, and digital security.
• Support other projects and responsibilities as needed.

Qualifications

• Bachelor’s Degree Engineering, Biomedical Engineering, Computer Science / Software Engineering, Medical Device Cybersecurity or Information Security or other specialization based on the specific coverage.
• 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.
• 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.

Total Rewards

We 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 bonus 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.

Disclaimer: This role is gender-neutral and open to all qualified applicants, regardless of gender identity or expression

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.