Senior Regulatory Affairs Specialist
Solventum
full-time
Posted on:
Location Type: Remote
Location: Minnesota • United States
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Salary
💰 $131,750 - $170,500 per year
Job Level
About the role
- Managing the regulatory compliance for a broad portfolio of medical devices
- Support teams in early and late-stage product development to advance the product through milestones and regulatory activities
- Build strong relationships across stakeholders, management, and contract organizations
- Developing and executing regulatory strategies
- Participating in global business and functional strategic meetings
- Performing regulatory assessments and determining registration plans
- Submitting registration documents until regulatory authorization is obtained
- Acting as the focal point for commercial support pertaining to all regulatory activities
- Managing regulatory systems and tools to ensure regulatory data integrity
- Reviewing advertising and promotional materials
- Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits
Requirements
- Bachelor’s Degree or higher (completed and verified prior to start) AND seven (7) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment
- High School Diploma/GED (completed and verified prior to start) and eleven (11) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment
- Three (3) years of experience with electromechanical medical devices
- Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions
Benefits
- Medical
- Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceregulatory strategiesregulatory assessmentsregistration plans510(k) submissionsEU MDR submissionselectromechanical medical devicesregulatory submissionsmedical device regulations
Soft skills
relationship buildingstakeholder managementcommunicationteam supportstrategic participation
Certifications
Bachelor’s DegreeHigh School Diploma/GEDISO 13485