Remote Senior Regulatory Affairs Leader

SOLVENTUM; Oregon; Hybrid; USD 124,000 - 171,000; Full time

Benefits offered by this job

Medical

Dental & Vision

Health Savings Accounts

Disability Benefits

Life Insurance

Voluntary Benefits

Paid Absences and Retirement Benefits

Job summary

Solventum, a healthcare solutions company, is hiring a Senior Regulatory Affairs Specialist in a remote US position. You will develop regulatory strategies, manage complex interdepartmental decisions, and prepare submissions to medical device regulators.

The role emphasizes global registration knowledge, audits support (ISO 13485, MDSAP), and ensuring claims align with cleared materials. Travel up to 10% and relocation not offered.

Qualifications

• Bachelor’s Degree or higher and 7+ years Regulatory Affairs experience; or HS Diploma with 11+ years Regulatory Affairs experience.
• Master’s Degree or higher in scientific, regulatory, or quality discipline is a plus.
• Three years of experience preparing regulatory submissions (510(k), EU MDR, etc.).
• Three years of experience supporting ISO 13485 and/or MDSAP audits.

Responsibilities

• Develop and execute regulatory strategies to accelerate product market authorizations.
• Manage cross-functional stakeholder decisions in regulatory areas.
• Represent Regulatory Affairs in global business and strategy forums.
• Prepare and submit regulatory documents and oversee evaluations until authorization.
• Act as focal point for commercial support on regulatory activities.
• Support ISO 13485, MDSAP audits and regulatory system integrity.

Skills

Regulatory strategy

Cross-functional collaboration

Global registrations

Education

Bachelor’s degree or higher

Master’s degree (additional)

Job description

Solventum, a healthcare solutions company, is hiring a Senior Regulatory Affairs Specialist in a remote US position. You will develop regulatory strategies, manage complex interdepartmental decisions, and prepare submissions to medical device regulators.

The role emphasizes global registration knowledge, audits support (ISO 13485, MDSAP), and ensuring claims align with cleared materials. Travel up to 10% and relocation not offered.