Regulatory Affairs Specialist
Solventum
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $85,200 - $117,150 per year
About the role
- Support regulatory affairs on cross functional teams
- Own processes in Regulatory Operations for the dental solutions business
- Manage the processes involved in regulatory submissions and approvals
- Oversee RIM systems that centralize regulatory data and streamline processes
- Work with international regulatory affairs to ensure products are registered globally
- Support Regulatory Operations during the company spin-off
- Support certificate requests for ongoing country registrations
- Communicate results of technical tasks to teams via reports, standards and/or presentations
- Demonstrate operational and strategic mindset with strong prioritization, oral and written communication skills
Requirements
- Bachelor’s Degree or higher from an accredited university
- 2+ years in regulatory affairs, with knowledge of ISO 13485, MDSAP, EU MDR, and other global regulatory frameworks
- Experience authoring submissions/technical documentation for global regions
- Direct experience authoring regulatory strategies and regulatory change assessments
- Direct experience using a Regulatory Management Software solution
- Direct experience in major cross functional initiatives/projects
- Proficient in Office Suite
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 & Tools
regulatory submissionsregulatory strategiestechnical documentationregulatory change assessmentsRegulatory Management SoftwareISO 13485MDSAPEU MDR
Soft Skills
prioritizationoral communicationwritten communicationoperational mindsetstrategic mindset