Regulatory Affairs Administrator (m/f/x)*

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

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 Coordinator (m/f/x)* 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 30+ rebranding CMPs for EMEA MedSurg Business (Solventum plants & vendors)

• Support with process improvement and make it faster while remaining compliant

• Support of redline creation of artworks and do the approvals of incoming rebranded artworks

• Prepare and update technical documentation for Class I, IIa, IIb, and III medical devices in compliance with EU MDR and ISO 13485.

• Reg Desk to support SOS RAs (setting up trackings for EU and DCTs)

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

• Fluent written and verbal English skills

• Good understanding of regulatory processes of medical devices

• Good knowledge in corporate quality management systems

• Knowledge in technical documentation for Class I, IIa, IIb, and III medical devices in compliance with EU MDR and ISO 13485

• Good communication skills, ability to escalate open topics and follow up on completion

• Project coordination and problem-solving in dynamic environments

This position is limited to 18 months.

Work location:

• Hybrid Eligible (Job Duties allow for some remote work but require travel to Düsseldorf at least 1 day per week)

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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