Senior Regulatory Affairs Specialist - Remote

Overview

As a Senior Regulatory Affairs Specialist at Solventum, you will lead regulatory affairs on cross-functional teams, managing product line submissions and registrations globally for the dental solutions business.

In Short

• Lead regulatory affairs for dental solutions.
• Conduct global regulatory change assessments.
• Provide regulatory review of technical documents.
• Manage metrics and documentation.
• Support labeling and registration changes.
• Communicate results to teams and stakeholders.
• Implement key corporate initiatives.
• Work closely with international regulatory affairs group.
• May require up to 10% international travel.
• Remote work opportunity within Italy.

Requirements

• Bachelor’s Degree in a scientific discipline.
• 7-10 years in regulatory affairs in the medical device industry.
• Experience with submissions for US, Canada, EU, and other regions.
• Expertise in design control and clinical requirements.
• Strong technical writing and verbal skills in English.
• Experience in project management and stakeholder management.
• Knowledge of regulatory management software.
• Experience in the dental device field is a plus.

Benefits

• Competitive pay and benefits.
• Programs to support physical and financial well-being.
• Diversity and inclusion initiatives.
• Opportunities for professional growth and development.