Solventum logo
Solventum

Enabling better, smarter, safer healthcare to improve lives.

Principal Regulatory Affairs Specialist

ComplianceComplianceFull TimeRemoteLeadTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

Minnesota

Posted

1 day ago

Salary

$142.8K - $196.4K / year

Seniority

Lead

Bachelor Degree7 yrs expEnglish

Job Description

Principal Regulatory Affairs Specialist

Solventum

• 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

Job Requirements

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

Benefits

  • Medical
  • Dental & Vision
  • Health Savings Accounts
  • Health Care & Dependent Care Flexible Spending Accounts
  • Disability Benefits
  • Life Insurance
  • Voluntary Benefits
  • Paid Absences
  • Retirement Benefits

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