Senior Regulatory Affairs Specialist; Remote

Job Description:

Senior Regulatory Affairs Specialist

As a Senior Regulatory Affairs Specialist, you will have responsibility for managing the regulatory compliance for a broad portfolio of medical devices within the Infection Prevention and Surgical Solutions and Negative Pressure Wound Technology businesses. The portfolio of devices includes both durable medical equipment and single-use disposable sterile and non‑sterile devices. This role will support teams in early and late‑stage product development to advance the product through critical milestones and regulatory activities that lead to global product approvals.

In addition, this role will support on‑going product compliance throughout the device's lifecycle. You will actively build strong relationships across stakeholders, management, and with contract organizations.

In this role, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Developing and executing regulatory strategies to achieve new product market authorizations faster than competitors and with differentiated indications and claims
• Managing complex decision‑making among cross‑functional stakeholders in an area of regulatory that is complex and evolving
• Participating in global business and functional strategic meetings and forums representing regulatory affairs
• Performing regulatory assessments and determining registration plans with business for strategic implementation
• Articulating global registration requirements and compiling regulatory documents according to local regulatory requirements
• Submitting registration documents and following through on all in‑process evaluations until regulatory authorization is obtained
• Acting as the focal point for commercial support pertaining to all regulatory activities
• Managing regulatory systems and tools to drive operational excellence for effective data tracking and ensure regulatory data integrity
• Reviewing advertising and promotional materials to ensure claims are aligned with cleared claims
• Keeping abreast of new regulations and providing necessary regulatory information, updates, and documentation to the organization
• Supporting ISO 13485, Medical Device Single Audit Program, and Technical Surveillance audits
• Supporting any other duties within the role or tasks assigned from time to time

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor's Degree or higher (completed and verified prior to start) AND seven (7) years of experience in Regulatory Affairs & Medical Device experience in a private, public, government or military environment
• OR High School Diploma/GED (completed and verified prior to start) and eleven (11) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment

AND

In addition to the above requirements, the following are also required:

• Three (3) years of experience with electromechanical medical devices
• Three (3) years of experience with regulatory submissions which include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions

Additional qualifications that could help you succeed even further in this role include:

• 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 which may include: 510(k) submissions, EU MDR submissions, and/or other international medical device regulations and submissions.
• 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 with supporting 13485 and MDSAP audits.

• Remote in the United States

May include up to 10% domestic/international

Not…