Senior Regulatory Affairs Specialist; Remote

Senior Regulatory Affairs Specialist (Remote - United States)

Apply for the Senior Regulatory Affairs Specialist (Remote - United States) role at Solventum.

$/yr - $/yr

Solventum is a new healthcare company dedicated to enabling better, smarter, and safer healthcare. Guided by empathy, insight, and clinical intelligence, we collaborate with leading minds to address our customers’ toughest challenges and improve lives.

At Solventum, we pioneer game‑changing innovations at the intersection of health, material, and data science. As a Senior Regulatory Affairs Specialist, you will manage regulatory compliance for a broad portfolio of medical devices in both the Infection Prevention and Surgical Solutions and Negative Pressure Wound Technology businesses. You will support early and late‑stage product development, advance products through critical milestones, and maintain ongoing compliance throughout the device lifecycle.

You will collaborate closely with cross‑functional teams, stakeholders, and contract organizations to achieve timely product approvals.

• Develop and execute regulatory strategies to achieve new product market authorizations faster than competitors with differentiated indications and claims.
• Manage complex decision‑making among cross‑functional stakeholders in a rapidly evolving regulatory landscape.
• Participate in global business and functional strategic meetings and forums representing regulatory affairs.
• Perform regulatory assessments and determine registration plans with business for strategic implementation.
• Articulate global registration requirements and compile regulatory documents according to local regulatory requirements.
• Submit registration documents and follow through on all in‑process evaluations until authorization is obtained.
• Act as the focal point for commercial support for all regulatory activities.
• Manage regulatory systems and tools to drive operational excellence for effective data tracking and ensure regulatory data integrity.
• Review advertising and promotional materials to ensure claims are aligned with cleared claims.
• Keep abreast of new regulations and provide necessary regulatory information, updates, and documentation to the organization.
• Support ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits.
• Support any other duties within the role or tasks assigned from time to time.

• Bachelor’s Degree or higher (completed and verified prior to start) AND 7 years of experience in Regulatory Affairs & Medical Device in any environment.
• High School Diploma/GED (completed and verified prior to start) and 11 years of experience in Regulatory Affairs & Medical Device in any environment.
• Three (3) years of experience with electromechanical medical devices.
• Three (3) years of experience with regulatory submissions including 510(k) submissions, EU MDR submissions, and/or other international medical device regulations.

• Bachelor’s Degree or higher in electrical engineering, mechanical engineering, or software engineering/programming.
• Advanced degree in Scientific, Engineering, or Regulatory/Quality.
• Five (5) years of experience with electromechanical medical devices.
• Five (5) years of experience with regulatory submissions including 510(k) submissions, EU MDR submissions, and/or other international medical device regulations.
• Experience with temperature management, negative pressure wound devices, and/or wound care devices.
• Experience with stand‑alone software devices and cybersecurity.
• Three (3) years of experience supporting ISO 13485 and MDSAP audits.

Remote in the United States.

May include up to 10% domestic/international travel.

Not authorized.

Must be legally authorized to work in the country of employment without sponsorship for employment visa status (e.g., H1B status).

Solventum offers programs to help you live your best life – physically and financially, including Medical, Dental & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, Retirement Benefits, and more. Benefits are available to U.S. applicants only.

Solventum is an equal‑opportunity employer and will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Your application may not be considered if you do not provide your education and work history, either by uploading a resume or entering the information into the application fields directly.