Senior Regulatory Affairs Specialist; Remote

At Solventum, we improve lives by helping healthcare professionals do their best work. Join a team using innovation and insight to make a real impact on the future of healthcare. All roles listed are with Solventum, and we're committed to protecting your personal information—learn more in our Privacy Policy.

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.

• 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 areas of regulation that are complex and evolving.
• Participating in global business and functional strategic meetings and forums while 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, support 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 (MDSAP), and Technical Surveillance audits.
• Supporting additional duties and completing other responsibilities or projects as assigned.

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

• Master's Degree or higher in a scientific, engineering, regulatory, or quality discipline.
• Three (3) years of experience preparing and/or supporting regulatory submissions, including 510(k) submissions, EU MDR submissions, or other international medical device regulatory submissions.
• Three (3) 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.

• Remote (United States)

Travel:
May include…