Principal Regulatory Affairs Specialist (Remote - United States)

Principal Regulatory Affairs Specialist – Solventum Impact You’ll Make in this Role Serve as regulatory affairs lead on cross‑functional teams, owning product‑line regulatory submissions and registrations for the Dental Solutions business in global markets. Drive regulatory strategy and execution for tier‑1 high‑volume markets, including the United States, Canada, and the European Union, partnering with international teams. Conduct global regulatory change assessments and coordinate associated activities for assigned drug and medical device products. Lead or support regulatory filings for continuity and lifecycle projects, directly for the United States and European Union, and globally in partnership with rest‑of‑world teams. Provide regulatory review and input on technical documentation and reports, supporting labeling and registration updates related to the company spin‑off. Contribute to development, implementation, and continuous improvement of regulatory processes, documentation, and relevant metrics. Support risk management, vigilance reporting, and other quality‑related initiatives with minimal oversight. Communicate regulatory outcomes and technical information to cross‑functional teams, business partners, and regional stakeholders through reports, standards, and presentations. Support implementation of key corporate initiatives and enabling tools, including emerging digital and AI‑enabled solutions within the regulatory environment. Your Skills and Expertise Bachelor’s degree or higher completed and verified prior to start. Ten (10) years of regulatory affairs experience in the drug and/or medical device industry. Experience authoring regulatory submissions and technical documentation for drug and medical device products in the United States, Canada, and the European Union, with experience supporting regulatory activities in EMEA, APAC, and LATAM. Experience authoring regulatory strategies and regulatory change assessments. Experience revising, reviewing, and approving product labeling, including marketing claims, to ensure compliance with global regulatory requirements. Experience with dental products, including NDA and OTC monograph drugs and medical devices. Additional qualifications (not required but advantageous) include advanced degree in Biology, Chemistry, or Biomedical Engineering. Experience supporting design control verification and validation activities, including clinical requirements for medical devices. Experience supporting or contributing to clinical strategy activities for medical device products. Experience with formulated products and fluoride‑containing drug and medical device products. Experience working with borderline products such as drugs, cosmetics, and/or natural health products. Experience applying regulatory knowledge through cross‑functional project management, stakeholder engagement, international submission support, and resolving regulatory issues across medical device product teams. Experience applying regulatory principles to address complex regulatory issues and developing clear regulatory documentation and written communications. Experience applying structured process‑improvement approaches within regulatory or quality‑related workflows, including participation in training or professional development activities. Experience working across multiple product portfolios, technologies, or business areas, using regulatory information resources, systems, and data sources to support decision‑making. Remote location in the United States. May include up to 10% domestic and international travel. Must be legally authorized to work in the United States without sponsorship for an employment visa. Benefits and Compensation Compensation range: $142,800 – $196,350 (base pay plus variable incentive pay, if eligible). Benefits include Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and Retirement Benefits. Equal Opportunity and Legal Solventum is an equal‑opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Candidates must provide education and work history information. The privacy policy applies to all applicants. #J-18808-Ljbffr USA SOLVENTUM US LLC