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Responsibilities
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.The Impact You’ll Make in this RoleAs 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 (MDR), and CanadaSupporting international regulatory teams with product registrations across the Custom Smiles PortfolioEnsuring compliance with global regulations and reviewing technical and software documentation for submissionsCollaborating cross-functionally to integrate regulatory requirements into product developmentYour Skills and ExpertiseTo set you up for success ventum 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 devicesOR High School Diploma/GED and eleven (11) years of regulatory affairs experience in medical devicesAND following are also required:Five (5) years of experience with Software as a Medical Device (SaMD)Experience authoring 510(k) submissions for SaMDExperience supporting regulatory submissions in the United States and European UnionAdditional qualifications that could help you succeed even further in this role include:Master’s degree in Regulatory AffairsExperience supporting regulatory submissions in CanadaRegulatory Affairs Certification (RAC)Experience working with dental or orthodontic medical devicesExperience applying IEC 62304 standards and Software as a Medical Device (SaMD) lifecycle requirementsExperience preparing and reviewing regulatory documentation and submissionsExperience communicating regulatory requirements, risks, and outcomes through written reports, presentations, or cross-functional discussionsExperience collaborating with cross-functional teams (e.g., R&D, Quality, Clinical, and Commercial) to support regulatory activitiesSupporting Your Well-beingSolventum 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.Applicable to US Applicants Only: The expected compensation range for this position is $142,800 - $196,350, which includes base pay plus variable incentive pay, if eligible.Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.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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