Job Description

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.

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 Operations Specialist (m/f/*), you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Manage and maintain regulatory documentation required for international market access (e.g. certificates, Declarations of Conformity, Free Sale Certificates, LoA, etc.)
• Coordinate notarization, legalization, and apostille processes for international submissions
• Support the preparation and compilation of documentation for international regulatory submissions
• Ensure compliant document control, versioning, and archiving across regulatory systems
• Collaborate with Regulatory Affairs, Quality, Supply Chain, and regional teams to ensure timely and accurate execution of regulatory operational activities

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 AND first regulatory affairs experience in medical devices OR
• High School Diploma/GED AND several years of regulatory affairs experience in medical devices

AND

In addition to the above requirements, the following are also required:

• Experience managing regulatory records, certificates or other controlled documents
• Experience using electronic document management systems, databases, or regulatory information management system
• Fluent English communication skills, both written and verbal.
• Current, valid Driver’s License

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

• Experience supporting global medical device registrations and regulatory operational processes
• Knowledge of EU MDR, FDA regulations, international market registration requirements, or other healthcare regulatory frameworks
• Experience with systems such as PLM systems, document management systems, SharePoint, or similar electronic platforms
• Strong organizational skills with the ability to manage multiple projects and competing priorities
• Ability to work effectively in a global, cross-functional environment and drive continuous process improvements

Work location:

• Hybrid Eligible (Job Duties allow for some remote work but require travel to Seefeld at least 3 days per week)

Travel: May include up to 5 % domestic travel

Relocation Assistance: Not be authorized

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 on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community.

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