Principal Regulatory Affairs Specialist (Remote - United States)

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:

Principal Regulatory Affairs Specialist (Solventum)

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 Principal Regulatory Affairs Specialist, 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:

• Leading preparation and submission of 510(k) applications and other regulatory filings for Software as a Medical Device (SaMD)
• Developing and executing global regulatory strategies for product registrations in the US, EU (MDR), and Canada
• Supporting international regulatory teams with product registrations across the Custom Smiles Portfolio
• Ensuring compliance with global regulations and reviewing technical and software documentation for submissions
• Collaborating cross-functionally to integrate regulatory requirements into product development

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 (completed and verified prior to start) and seven (7) years of regulatory affairs experience in medical devices

OR

• High School Diploma/GED and eleven (11) years of regulatory affairs experience in medical devices

AND

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

• Five (5) years of experience with Software as a Medical Device (SaMD)
• Experience authoring 510(k) submissions for SaMD
• Experience supporting regulatory submissions in the United States and European Union

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

• Master’s degree in Regulatory Affairs
• Experience supporting regulatory submissions in Canada
• Regulatory Affairs Certification (RAC)
• Experience working with dental or orthodontic medical devices
• Experience applying IEC 62304 standards and Software as a Medical Device (SaMD) lifecycle requirements
• Experience preparing and reviewing regulatory documentation and submissions
• Experience communicating regulatory requirements, risks, and outcomes through written reports, presentations, or cross-functional discussions
• Experience collaborating with cross-functional teams (e.g., R&D, Quality, Clinical, and Commercial) to support regulatory activities

Work location:

• Remote

Travel: May include up to 5% domestic travel

Relocation Assistance: Not authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B 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 ben