Senior Medical Device Cybersecurity Regulatory Lead

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

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