Principal Regulatory Affairs Specialist (Remote - United States)

The Role

As a Principal Regulatory Affairs Specialist at Solventum, you will have the opportunity to lead the preparation and submission of 510(k) applications and other regulatory filings for Software as a Medical Device (SaMD). You will also develop and execute global regulatory strategies for product registrations in the US, EU (MDR), and Canada, and support international regulatory teams with product registrations across the Custom Smiles Portfolio.

You will ensure compliance with global regulations and review technical and software documentation for submissions, and collaborate cross-functionally to integrate regulatory requirements into product development.

Qualifications

• Bachelor’s Degree or higher (completed and verified prior to start) and seven (7) years of regulatory affairs experience in medical devices
• 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

Additional Qualifications

• 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

Benefits

• Competitive pay and benefits
• Healthcare and Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• Retirement Benefits

Work Location

Remote

Travel

May include up to 5% domestic travel

Relocation Assistance

Not authorized

Equal Opportunity Employer

Solventum is an equal opportunity employer and does not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

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