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Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. 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 Manager, Regulatory Affairs (Solventum)3M Health Care is now Solventum: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 Regulatory Affairs Senior Manager, you will lead all regulatory intelligence efforts for the Regulatory and Quality Affairs group and the greater Solventum business.This role will serve as a primary point of contact to RAQA and Solventum Executive Management, as a key contributor to governance decisions for strategic alignment and direction for the overall business strategy. This role will support all global teams to provide the platforms, systems and policies necessary to gather, assess and communicate on vital intelligence and policy critical to the business in the regulatory and quality compliance space.You will actively build strong relationships across stakeholders, management, and with contract organizations.As a Regulatory Affairs Senior Manager, 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:Responsible for all regulatory intelligence and regulatory policy supporting the Solventum Regulatory and Quality Assurance team and broader business which includes: collecting, analyzing, and communicating information on emerging and changing regulatory requirements, policies, standards and guidelines/guidance that may impact the development, approval, manufacturing, distribution, surveillance, and registrations of medical and life science productsPrimary liaison and responsible for engaging with the Solventum government affairs team and any pertinent external trade organizations, including AdvaMed and other global organizationsAdvising and guiding the regulatory and quality executive leadership on regulatory strategy development, Health Authority interactions, and submission activities pertaining to evolving intelligence and regulation/policy changesPartnering with business in supporting new venture initiatives and acquisitions/ integrationsPartnering with health economics, reimbursement, and government affairs to influence regulations globally to provide the best product position/price for our patientsYour Skills and ExpertiseTo set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:Bachelor's Degree or higher AND ten (10) years of experience in Regulatory Aff irs & Medical Device experience in a private, public, government or military environmentAdditional qualifications that could help you succeed even further in this role include:Experience with 510(k) applications, EU MDR submissions, and other international medical device regulations and submissions.Previous experience working directly with global competent authorities (e.g. US FDA, Health Canada, NPMA)Previous experience with leading or participating in global regulatory intelligence and policy programs for a Medical Technology companyExcellent verbal and written communication skillsLanguages: German, Spanish, FrenchGlobal regulatory affairs experience in the MedTech industryWork location: Remote - United StatesTravel: May include up to 20% domestic/internationalRelocation Assistance: May be authorizedMust be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).Supporting Your Well-beingSolventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.Applicable to US Applicants Only:The expected compensation range for this position is $207,348 - $253,425, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position...Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity