Senior Regulatory Affairs Specialist (Remote - United States)

SOLVENTUM•Remote - Texas, TX

9d•$124,000 - $170,500•Remote

About The Position

Solventum is seeking a Senior Regulatory Affairs Specialist to lead a regulatory affairs team primarily supporting its Restorative Healing Technologies portfolio, a strategic growth area with corporate-wide impact. The role supports early- and late-stage product development, regulatory milestones and activities leading to global product approvals, and ongoing product compliance throughout the medical device lifecycle. The specialist builds relationships with stakeholders, management, and contract organizations, and develops a team with the capacity and competence to support business strategy. The role develops and executes regulatory strategies for new product authorizations, supports complex cross-functional regulatory decisions, and represents Regulatory Affairs in global business and functional forums. It also covers regulatory assessments, registration planning and submissions, commercial regulatory support, regulatory systems and data integrity, promotional material review, monitoring regulatory developments, and support for quality-system and medical-device audits. The position is remote within the United States and may include up to 10% domestic or international travel. Relocation assistance is not authorized.

Requirements

Bachelor’s degree or higher and at least seven years of Regulatory Affairs experience within a regulated industry; alternatively, a high school diploma/GED and at least eleven years of such experience.
Must be legally authorized to work in the country of employment without employment visa sponsorship.
Provide education and work history, either by uploading a resume or entering the information into the application fields.

Nice To Haves

Master’s degree or higher in a scientific, engineering, regulatory, or quality discipline.
Three years of experience preparing and/or supporting regulatory submissions, including 510(k), EU MDR, or other international medical-device submissions.
Three years of experience supporting ISO 13485 and/or MDSAP audits.
Experience supporting regulatory activities for negative pressure wound therapy devices and/or wound care medical devices.
Experience supporting regulatory activities for absorbable wound care dressings and matrices.
Experience supporting regulatory activities for electro-mechanical devices and/or embedded or stand-alone software medical devices.

Responsibilities

Develop and execute regulatory strategies to achieve new product market authorizations, including differentiated indications and claims.
Manage complex regulatory decision-making with cross-functional stakeholders in complex and evolving regulatory areas.
Participate in global business and functional strategic meetings and forums as the Regulatory Affairs representative.
Perform regulatory assessments and determine registration plans with the business for strategic implementation.
Explain global registration requirements and compile regulatory documents according to local requirements.
Submit registration documents and follow in-process evaluations through to regulatory authorization.
Serve as the focal point for commercial support related to regulatory activities.
Manage regulatory systems and tools to improve operational excellence and data tracking, and ensure regulatory data integrity.
Review advertising and promotional materials to ensure claims align with cleared claims.
Monitor new regulations and provide regulatory information, updates, and documentation to the organization.
Support ISO 13485, MDSAP, and Technical Surveillance audits.
Complete additional assigned duties and projects.
Ensure corporate policies, procedures, and security standards are followed while performing assigned duties.
Build and develop a regulatory affairs team with the capacity and competence to support business strategic plans.