Regulatory Affairs Program Manager (m/f/x) · for Medical Software, Cybersecurity & AI/Digital Health

Thank you for your interest in joining Solventum. 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. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit.

As it was with 3M, at Solventum 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.

Job Description:

By applying to this position, you acknowledge that Solventum recently publicly announced its intention to divest its Health Information Systems Business. See Solventum Announces Intent to Separate its Health Information Systems Business :: Solventum Corporation Newsroom . No decision has been made regarding the ultimate structure or timing of any potential transaction, and there can be no assurance that a separation will occur. Any transaction would be subject to customary approvals, including approval by Solventum's Board of Directors, regulatory requirements and other customary conditions. This position supports the Health Information Systems Business. If a future transaction involving that business were to occur, the impact on this role would be determined as part of that process and would remain subject to applicable legal requirements, approvals and business decisions.

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, 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. Because at Solventum, we never stop solving for you.

The Impact You'll Make in this Role

As a Regulatory Affairs Program Manager (m/f/x)* for Medical Software, Cybersecurity & AI/Digital Health you will serve as a regulatory subject matter expert for software and medical devices,. You will partner across Regulatory Affairs, R&D, Software Engineering, Product Security, Quality, Clinical, and Product teams to ensure software and cybersecurity regulatory requirements are built into product strategy, development, submissions, and post-market lifecycle management. Here, you will make an impact by:

• Developing and implementing global regulatory strategies and submissions for medical device software, and other digital health software, including CE marking and other global market access pathways. Ensuring compliance with current and emerging EMEA and global regulatory and standards requirements affecting medical software, and software-related quality system expectations.
• Compiling and reviewing regulatory dossiers and technical documentation, including, software risk management, verification and validation evidence, cybersecurity documentation, and AI-related documentation where applicable.
• Supporting the quality management system processes governing software lifecycle, design controls, risk management, cybersecurity, change control, complaint handling, vigilance, and post-market surveillance for the product portfolio.
• Communicating with authorities, notified bodies, consultants, distributors, and internal stakeholders processing country-specific requests for global marketing authorizations and supporting bid and tender submissions as needed.
• Providing training, regulatory intelligence assessments, and practical interpretation to cross-functional teams on software, cybersecurity, AI, and digital health regulatory requirements.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's Degree or higher in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, Information Technology, Regulatory Affairs, or a related scientific/technical discipline (completed and verified prior to start).
• Significant experience in Medical Device Regulatory Affairs with demonstrated expertise supporting software-containing medical devices, me