Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

Tailor your resume to this Regulatory Affairs Program Manager (m/f/x)* for Medical Software, Cybersecurity & AI/Digital Health role.

Rezi rewrites your resume against SOLVENTUM's job description. Free.

Resume score gauge reading 58 out of 100

Don't guess if your resume is good enough.

See how it scores against the Regulatory Affairs Program Manager (m/f/x)* for Medical Software, Cybersecurity & AI/Digital Health posting at SOLVENTUM — free, in seconds.

About the Role

As a Regulatory Affairs Program Manager for Medical Software, Cybersecurity & AI/Digital Health, you will serve as a regulatory subject matter expert, partnering across various teams to ensure regulatory requirements are integrated into product strategy, development, submissions, and post-market lifecycle management.

Responsibilities

Develop and implement global regulatory strategies and submissions for medical device software and digital health software, including CE marking and other global market access pathways.
Ensure compliance with current and emerging EMEA and global regulatory and standards requirements affecting medical software and software-related quality system expectations.
Compile and review regulatory dossiers and technical documentation, including software risk management, verification and validation evidence, cybersecurity documentation, and AI-related documentation.
Support quality management system processes governing software lifecycle, design controls, risk management, cybersecurity, change control, complaint handling, vigilance, and post-market surveillance.
Communicate with authorities, notified bodies, consultants, distributors, and internal stakeholders regarding country-specific requests for global marketing authorizations and support bid and tender submissions.
Provide training, regulatory intelligence assessments, and practical interpretation to cross-functional teams on software, cybersecurity, AI, and digital health regulatory requirements.

Requirements

Bachelor’s Degree or higher in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Information Technology, Regulatory Affairs, or a related scientific/technical discipline.
Significant experience in Medical Device Regulatory Affairs with demonstrated expertise supporting software-containing medical devices, medical device software, or software as medical device.
Experience developing regulatory strategies and submissions for embedded and/or stand-alone medical software.
Working knowledge of medical device software and cybersecurity expectations, including software lifecycle, risk management, usability/human factors interface, cybersecurity documentation, and secure product development.
Practical familiarity with key software, cybersecurity, risk management, and quality system standards/guidance, such as IEC 62304, IEC 82304-1, IEC 81001-5-1, ISO 14971, ISO 13485, FDA software guidance, FDA cybersecurity guidance, EU MDR/MDCG software guidance, and applicable AI/digital health frameworks.
Ability to work independently.
Fluent in English and German language.
Must be legally authorized to work in country of employment without sponsorship for employment visa status.

Skills

Medical Software
Cybersecurity
AI/Digital Health
Regulatory Affairs
Software Engineering
Product Security
Quality Assurance
Clinical Affairs
Product Management
Medical Device Software
Software Risk Management
Verification and Validation
Cybersecurity Documentation
AI Documentation
Quality Management System
Design Controls
Change Control
Complaint Handling
Vigilance
Post-Market Surveillance
Global Marketing Authorizations
Bid and Tender Submissions
Regulatory Intelligence
IEC 62304
IEC 82304-1
IEC 81001-5-1
ISO 14971
ISO 13485
FDA Software Guidance
FDA Cybersecurity Guidance
EU MDR/MDCG Software Guidance
AI/Digital Health Frameworks
Advanced degree in Regulatory Affairs, Computer Science, Software Engineering, Biomedical Engineering, Cybersecurity, or a related technical discipline.
Certification or formal training in AI/ML, cybersecurity, secure software development, regulatory affairs, or quality systems.
EU AI Act
EU Cyber Resilience Act
FDA AI/ML expectations
Good Machine Learning Practice principles
Executive Communication
Training
Presentation Skills
MS Office/Microsoft 365

Location

Hybrid

Work Type

Hybrid
Full-time

Experience Level

Significant experience in Medical Device Regulatory Affairs

Education Level

Bachelor’s Degree or higher in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Information Technology, Regulatory Affairs, or a related scientific/technical discipline.
Advanced degree in Regulatory Affairs, Computer Science, Software Engineering, Biomedical Engineering, Cybersecurity, or a related technical discipline.

Benefits

Programs to help you live your best life – both physically and financially.
Competitive pay and benefits.

About the Company

Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best.
At Solventum, people are at the heart of every innovation we pursue.
Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges.
Solventum enables better, smarter, safer healthcare to improve lives.
We pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best.
Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.
We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy.
At Solventum, we never stop solving for you.

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.