Senior Regulatory Affairs Leader – Remote US

3mcompany; United States; Remote; USD 124,000 - 171,000; Full time

Job summary

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy for the Restorative Healing Technologies portfolio and guide product approvals globally while ensuring ongoing compliance across the lifecycle.

This remote United States role requires strong experience in submissions (510(k), EU MDR), ISO 13485, and cross-functional collaboration with development and QA teams to achieve timely market clearances.

Qualifications

• Bachelor’s Degree or higher in a scientific field with 7+ years of Regulatory Affairs experience.
• Master’s Degree or higher in a regulatory or quality discipline is a plus.
• Experience preparing and supporting ISO 13485 and MDSAP audits.

Responsibilities

• Develop regulatory strategies to achieve new product market authorizations globally.
• Lead regulatory submissions and registrations across US and international markets.
• Collaborate with cross-functional teams and contract organizations to ensure compliance.

Skills

Regulatory strategy

510(k) submissions

EU MDR submissions

ISO 13485

MDSAP

Cross-functional collaboration

Leadership

Education

Bachelor’s Degree in a scientific field

Master’s Degree in regulatory/quality discipline

Job description

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy for the Restorative Healing Technologies portfolio and guide product approvals globally while ensuring ongoing compliance across the lifecycle.

This remote United States role requires strong experience in submissions (510(k), EU MDR), ISO 13485, and cross-functional collaboration with development and QA teams to achieve timely market clearances.