Senior Regulatory Affairs Lead – Global Medical Devices

SOLVENTUM; Austin (TX); Remote; USD 124,000 - 171,000; Full time

Job summary

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for Restorative Healing Technologies on a global scale. This remote US role emphasizes building regulatory strategy, coordinating cross-functional teams, and ensuring compliance from development through lifecycle management.

You will drive registrations, submissions, and post-market obligations while collaborating with contract organizations and stakeholders across regions.

Qualifications

• Bachelor’s degree (or higher) with 7+ years regulatory affairs experience in a regulated industry.
• Experience with 510(k), EU MDR or other international medical device submissions.
• Experience supporting ISO 13485 and/or MDSAP audits.
• Experience with regulatory activities for devices and software/embedded systems.

Responsibilities

• Develop regulatory strategies to achieve timely product market authorizations.
• Lead cross-functional decision-making on regulatory issues.
• Prepare and submit regulatory documents per local requirements.
• Maintain regulatory systems and data integrity to support operations.
• Support ISO 13485 and MDSAP audits and regulatory inspections.
• Advise on post-market regulatory obligations throughout product lifecycle.

Skills

Regulatory strategy

Cross-functional liaison

Compliance management

Auditing support

Education

Bachelor's degree or higher

High school diploma or GED

Tools

ISO 13485

MDSAP audits

510(k) submissions

EU MDR submissions

Job description

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for Restorative Healing Technologies on a global scale. This remote US role emphasizes building regulatory strategy, coordinating cross-functional teams, and ensuring compliance from development through lifecycle management.

You will drive registrations, submissions, and post-market obligations while collaborating with contract organizations and stakeholders across regions.