Remote Senior Regulatory Affairs Lead, Medical Devices

SOLVENTUM

Texas

Remote

USD 120,000 - 170,000

Full time

6 days ago

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Benefits offered by this job

Medical, Dental & Vision

Retirement Benefits

Paid Time Off

Remote work option

Job summary

Solventum, a health care innovator, seeks a Senior Regulatory Affairs Specialist to lead a team supporting Restorative Healing Technologies and drive global product approvals. You will develop regulatory pathways, align strategies with business goals, and ensure lifecycle compliance.

Responsibilities include preparing submissions (510(k), EU MDR), guiding regulatory activities, and coordinating with internal and contract partners to meet milestones. Remote US work available.

Qualifications

Bachelor's degree or higher with 7+ years of regulatory affairs experience.
Experience with 510(k), EU MDR, and international medical device submissions.
Experience supporting regulatory activities for wound care devices and electro-mechanical devices.
Ability to lead a regulatory affairs team and collaborate with cross-functional teams.

Responsibilities

Develop regulatory strategies to achieve market authorizations globally.
Lead global registration projects and compile regulatory documents.
Support ISO 13485, MDSAP, and audits across programs.
Coordinate with contract organizations and key stakeholders.

Skills

Regulatory strategy

Team leadership

Global registrations

Documentation

Regulatory submissions

Education

Bachelor's degree

Master's degree

Tools

Regulatory databases

Audits support

Job description

Responsibilities include preparing submissions (510(k), EU MDR), guiding regulatory activities, and coordinating with internal and contract partners to meet milestones. Remote US work available.

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