[Hiring] Principal Regulatory Affairs Specialist @SOLVENTUM

Role Description

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

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
• 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

Requirements

• 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, regularly benchmarked with other companies
• Expected compensation range for this position is $142,800 - $196,350, including base pay plus variable incentive pay, if eligible
• This position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.)