Senior Regulatory Affairs Lead - Global Medical Devices (Remote)

Solventum; Maplewood (NJ); Remote; USD 124,000 - 171,000; Full time

Benefits offered by this job

Remote work in the US

Competitive compensation

Job summary

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for the Restorative Healing Technologies portfolio. Remote work is available in the United States with occasional travel up to 10%.

You will guide regulatory strategy, submissions, and lifecycle compliance across multiple regions. The role requires a strong track record in regulatory affairs within medical devices, plus experience with ISO 13485, MDSAP, and 510(k)/EU MDR submissions.

Qualifications

• Bachelor's Degree or higher AND seven (7) years of Regulatory Affairs experience in a regulated environment.
• High School Diploma/GED with eleven (11) years of Regulatory Affairs experience.

Responsibilities

• Develop regulatory strategies to obtain product market authorizations.
• Lead regulatory activities across global submissions and registrations.
• Provide regulatory input in cross-functional teams and audits.

Education

Bachelor's Degree or higher

Master's Degree (preferred)

Job description

Solventum is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for the Restorative Healing Technologies portfolio. Remote work is available in the United States with occasional travel up to 10%.

You will guide regulatory strategy, submissions, and lifecycle compliance across multiple regions. The role requires a strong track record in regulatory affairs within medical devices, plus experience with ISO 13485, MDSAP, and 510(k)/EU MDR submissions.