Senior Regulatory Affairs Leader — Remote Medical Devices

USA SOLVENTUM US LLC; Texas; Hybrid; USD 124,000 - 171,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Health Care & Dependent Care Flexible

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences

Retirement Benefits

Job summary

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and drive timely product approvals across global markets. You will guide a team, coordinate with product development, clinical, and quality assurance to ensure regulatory compliance throughout the lifecycle of Restorative Healing Technologies.

The role requires extensive experience in medical device regulatory submissions (510(k), EU MDR) and audits (ISO 13485, MDSAP), with remote/work-from-home flexibility

Qualifications

• Bachelor’s Degree or higher and seven (7) years of Regulatory Affairs experience in a regulated industry.
• High School Diploma/GED and eleven (11) years of Regulatory Affairs experience in a regulated industry.

Responsibilities

• Develop and execute regulatory strategies to achieve product market authorizations.
• Lead a regulatory affairs team and coordinate with cross-functional stakeholders.
• Represent Regulatory Affairs in global business and functional meetings.
• Prepare and support regulatory submissions including 510(k) and EU MDR submissions.
• Support ISO 13485 and MDSAP audits and regulatory activities for medical devices.

Skills

Leadership

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Education

Bachelor’s Degree or higher

High School Diploma/GED

Master’s Degree

Job description

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and drive timely product approvals across global markets. You will guide a team, coordinate with product development, clinical, and quality assurance to ensure regulatory compliance throughout the lifecycle of Restorative Healing Technologies.

The role requires extensive experience in medical device regulatory submissions (510(k), EU MDR) and audits (ISO 13485, MDSAP), with remote/work-from-home flexibility