Senior Regulatory Affairs Specialist (m / f / x) Join to apply for the Senior Regulatory Affairs Specialist (m / f / x) role at Solventum. Solventum is the successor of 3M Health Care following a corporate spin-off creating our new company. We are updating our Careers Page and applicant documents. Our Privacy Policy applies to any personal information you submit, and the Solventum-branded positions listed on our Careers Page are for Solventum positions. 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. Job Description Solventum enables better, smarter, safer healthcare to improve lives. As a new company with a long legacy, 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. We partner with the brightest minds in healthcare to ensure that every solution blends the latest technology with compassion and empathy. At Solventum we never stop solving for you. The Impact You’ll Make in this Role In this senior regulatory affairs position, you will 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. The role will have a significant impact for post-market maintenance in all markets Solventum serves. The position will work with the international regulatory affairs group to ensure products are registered globally based on the business strategy. In addition, you will have the opportunity to support labeling and registration changes due to the spin-off. As a Senior Regulatory Affairs Specialist (m / f / x), 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 : Conducting global regulatory change assessments and coordinating associated activities for assigned products. Demonstrating an operational and strategic mindset that is results-oriented with a strong bias towards speed, agility, and quality, in addition to excellent organizational, prioritization, oral and written communication skills. Providing regulatory review of technical reports and documents. Providing contributions for development and implementation of regulatory processes. Documenting and managing metrics. Leading regulatory filings as needed for continuity projects (directly for EU / USA, and supporting ROW). Supporting risk management activities, vigilance reporting activities, and other quality-related initiatives with minimal oversight. Communicating results of technical tasks to teams supported, respective business groups and / or country / region served via reports, standards and / or presentations. Leading the implementation of key corporate initiatives and appropriate tools. 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 from an accredited university in a scientific discipline such as Biology, Chemistry, Biomedical Engineering or Physics. 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 and LATAM regions. Direct experience authoring regulatory strategies and regulatory change assessments. Direct experience revising, reviewing and approving labeling (including marketing claims) that meet global regulatory requirements. Must have experience and expertise in design control verification and validation activities, as well as expertise in clinical requirements for medical devices; in particular, experience with assisting teams with documenting and performing to applicable requirements, and assisting with writing, reviewing and approving all protocols and reports. Expert technical writing and verbal skills in the English language. Additional qualifications that could help you succeed even further in this role include : Experience working in the dental device field or with dental products. Experience working with formulated products. Experience in project management. Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software. Work location : Remote within Italy Travel : May include up to 10% international Must be legally authorized to work in country of employment without sponsorship for employment visa status. Supporting Your Well-being Solventum offers programs to support your well-being and competitive pay and benefits. We benchmark with companies of similar size and scope. 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 maintaining the highest standards of integrity in our recruitment process. Applicants should remain alert to fraudulent job postings and recruitment schemes claiming to represent Solventum. Please note that all email communications from Solventum regarding job opportunities will be from an @solventum.com domain. Be wary of unsolicited emails from other domains. Please note : your application may not be considered if you do not provide your education and work history, either by uploading a resume or entering the information directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Access the linked document, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms. Seniority level Mid-Senior level Employment type Full-time Job function Public Relations Referrals increase your chances of interviewing at Solventum by 2x Sign in to set job alerts for “Senior Regulatory Affairs Specialist” roles. J-18808-Ljbffr J-18808-Ljbffr