Senior Regulatory Affairs Specialist (m/f/*)

Overview Senior Regulatory Affairs Specialist (m/f/*) at Solventum. Solventum is the company formed from the 3M Healthcare spin-off completed on April 1, 2024. The Privacy Policy applies to any personal information you submit, and 3M-branded positions listed on our Careers Page are for Solventum positions. As with 3M, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Responsibilities Act as the lead for regulatory affairs on cross-functional teams and own product line submissions and registrations across the globe for the dental solutions business. Support post-market maintenance in all markets Solventum serves and ensure products are registered globally based on the business strategy in collaboration with the international regulatory affairs group. Support labeling and registration changes due to the company spin-off. Conduct global regulatory change assessments and coordinate associated activities for assigned products. Demonstrate an operational and strategic mindset with a focus on speed, agility, and quality, backed by strong organizational, prioritization, and communication skills. Provide regulatory review of technical reports and documents. Contribute to development and implementation of regulatory processes and document and manage metrics. Lead regulatory filings for continuity projects (EU/USA directly; support for ROW). Support risk management activities, vigilance reporting, and other quality initiatives with minimal oversight. Communicate results of technical tasks to supported teams and respective business groups and regions via reports, standards, or presentations. Lead the implementation of key corporate initiatives and appropriate tools. Qualifications Bachelor’s Degree or higher in a scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering, Physics) from an accredited university. 7–10 years in regulatory affairs in the medical device industry. Direct experience authoring submissions/technical documentation for US, Canada, EU and supporting EMEA, APAC, LATAM regions. Direct experience authoring regulatory strategies and regulatory change assessments. Experience revising, reviewing, and approving labeling that meets global regulatory requirements. Experience with design control verification and validation activities and clinical requirements for medical devices; assist teams with documentation and protocols/reports. Excellent technical writing and verbal skills in English. Experience with dental devices or dental products, formulated products, and project management are a plus. Regulatory acumen, cross-functional project management, stakeholder management, international submission support; proficient in Office Suite and Regulatory Management Software. Work location & travel Remote within Italy. Travel may include up to 10% international. Additional information Must be legally authorized to work in the country of employment without sponsorship for employment visa status. Diversity & Inclusion: We are an equal opportunity employer and value diversity. We do not discriminate on the basis of race, religion, gender, sexual orientation, age, civil status, disability, family status, or membership of the travelling community. Solventum is committed to integrity and professionalism in our recruitment process. Be aware of fraudulent postings and ensure emails come from @solventum.com. Your application may require you to provide education and work history (resume upload or entry in application fields). Solventum Global Terms of Use and Privacy Statement: Carefully read the Terms of Use before using this website and submitting your application. J-18808-Ljbffr

Location: Italia, IT

Posted Date: 9/17/2025