Senior Regulatory Affairs Specialist (Remote - United States)

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Senior Regulatory Affairs Specialist

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As a Senior Regulatory Affairs Specialist, you will have responsibility for managing the regulatory compliance for a portfolio of medical devices within the Infection Prevention and Surgical Solutions business. The portfolio of devices includes Class Is, II and III in the EU as well as 510(k) requirements in the US.  This role will support on-going product compliance throughout the device’s lifecycle allowing you the opportunity to build strong relationships with stakeholders and management.

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 the 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 to ensure regulatory data integrity.
• 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.

Your Skills and Expertise 

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) from an accredited institution AND five (5) 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) from an accredited institution and nine (9) years of experience in Regulatory Affairs & Medical Device in a private, public, government or military environment

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

• 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