Senior Regulatory Affairs Leader – Remote Medical Devices

SOLVENTUM; Clifton (TX); Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental & Vision

Health Savings Accounts

Disability Benefits

Life Insurance

Retirement Benefits

Job summary

Solventum is hiring a Senior Regulatory Affairs Specialist to lead regulatory strategy for the Restorative Healing Technologies portfolio. You will drive global registrations, prepare submissions, and ensure lifecycle compliance for medical devices.

You will collaborate with stakeholders and contract organizations, oversee regulatory data, and guide teams through audits and compliance programs. This role is Remote (United States) with ~10% travel.

Qualifications

• Bachelor's Degree or higher completed and verified prior to start with regulatory experience.
• Seven (7) years of Regulatory Affairs experience in a regulated industry.
• High School Diploma/GED with eleven (11) years of Regulatory Affairs experience.
• Three (3) years of experience preparing and/or supporting regulatory submissions (510(k), EU MDR).
• Experience supporting regulatory activities for wound care and electro-mechanical devices.

Responsibilities

• Develop and execute regulatory strategies to achieve new product authorizations globally.
• Participate in global meetings representing Regulatory Affairs.
• Determine registration plans and compile regulatory documents.
• Submit registration documents and track evaluations to approval.
• Maintain regulatory systems, data integrity, and compliance.

Skills

Regulatory strategy

Global registration

Regulatory submissions

ISO 13485

Regulatory compliance

Education

Bachelor’s Degree or higher

High School Diploma/GED

Master’s Degree

Tools

Regulatory systems and tools

Job description

Solventum is hiring a Senior Regulatory Affairs Specialist to lead regulatory strategy for the Restorative Healing Technologies portfolio. You will drive global registrations, prepare submissions, and ensure lifecycle compliance for medical devices.

You will collaborate with stakeholders and contract organizations, oversee regulatory data, and guide teams through audits and compliance programs. This role is Remote (United States) with ~10% travel.