Regulatory Affairs 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:

3M Health Care is now Solventum

The Impact You’ll Make in this Role
As a Regulatory Affairs 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, 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, 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

Additional qualifications that could help you succeed even further in this role include:

• 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.

• Experience interpreting and applying EU AI Act, EU Cyber Resilience Act, FDA AI/ML expectations, Good Machine Learning Practice principles, and global digital health/software regulatory frameworks.

• Strong executive communication, training, and presentation skills; proficiency with MS Office/Microsoft 365 tools.

Work location: Hybrid

Travel: May include up to 10% domestic/international

Must be legally authorized to work in country of employment without sponsorship for employment visa status.

Supporting Your Well-being 

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. 

Diversity & Inclusion

(*) 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.

   

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.  Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

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