Senior Regulatory Affairs Lead - Remote Healthcare Devices

Solventum; Winters (TX); Remote; USD 124,000 - 171,000; Full time

Job summary

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for our Restorative Healing Technologies portfolio, driving global registrations and lifecycle compliance. You will collaborate with cross‑functional teams, prepare submissions (510(k), EU MDR), and mentor a regulatory group to ensure timely approvals.

The ideal candidate has 7+ years in Regulatory Affairs, ISO 13485 and/or MDSAP experience, and strong communication across stakeholders.

Qualifications

• Bachelor’s Degree or higher with 7+ years of Regulatory Affairs experience.
• High School Diploma with 11+ years of Regulatory Affairs experience.
• Experience preparing/regulatory submissions including 510(k) and EU MDR.
• Experience supporting ISO 13485 and/or MDSAP audits.

Responsibilities

• Lead a regulatory affairs team supporting Restorative Healing Technologies.
• Develop regulatory strategies to achieve product authorizations.
• Coordinate global registration documents and submissions.
• Ensure ongoing product compliance through lifecycle.
• Engage with cross-functional stakeholders and contract organizations.

Skills

Regulatory Affairs

510k submissions

EU MDR

ISO 13485

MDSAP

Education

Bachelor's Degree or higher

High School Diploma/GED alternative

Job description

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for our Restorative Healing Technologies portfolio, driving global registrations and lifecycle compliance. You will collaborate with cross‑functional teams, prepare submissions (510(k), EU MDR), and mentor a regulatory group to ensure timely approvals.

The ideal candidate has 7+ years in Regulatory Affairs, ISO 13485 and/or MDSAP experience, and strong communication across stakeholders.