Principal Regulatory Affairs Specialist (Remote - United States)

SOLVENTUM•Remote - Minnesota, MN

2d•$142,800 - $196,350•Remote

About The Position

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. 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. Solventum enables 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.

Requirements

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

Nice To Haves

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

Responsibilities

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
Corporate policies, procedures and security standards are complied with while performing assigned duties.