Regulatory Affairs Manager

Regulatory Affairs ManagerAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:Career development with an international company where you can grow the career you dream ofEmployees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.An excellent retirement savings plan with high employer contributionTuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degreeA company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by FortuneA company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientistsAt Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That's why we're focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.This Regulatory Affairs Manager position is an onsite opportunity working out of either our Alameda, CA, Milpitas, CA or Austin, TX for our Diabetes Care division.As a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio.WHAT YOU'LL DODrive U.S. regulatory strategy for new product and lifecycle management.Lead and mentor a team of regulatory professionals, fostering a culture of collaboration, development, and high performance.Partner cross-functionally with R&D, clinical, quality, and commercial teams to influence product development and ensure regulatory success.Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.Negotiate and interact with regulatory authorities during the development and review process to ensure timely submission approval.Ensure compliance excellence, balancing speed to market with robust regulatory standards.Anticipate and effectively communicate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with cross-functional teams.Execute and manage technical and scientific regulatory activities. Must function independently as a decisionmaker on regulatory issues and assure that deadlines are met.Develop, enhance and streamline regulatory policies, processes and SOPs and train team members. Evaluate regulatory risks of division policies, processes, procedures.Stay ahead of evolving regulatory requirements, guidance, and industry trends. Interpreting applicability and implementing changes to SOPs and submission documentation as required.Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Required QualificationsBachelor's Degree in a related field OR an equivalent combination of education and work experienceMinimum 4 years' experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.Domestic and international regulatory guidelines, policies and regulations.Lead functional groups in the development of relevant data to complete a regulatory submission.Preferred QualificationsBachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.Master's or Ph.D. in a technical area.Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).Previous experience with US (e.g. PMA, PMA/S, IDE, 510(k), etc.), CE (EU MDR) and international submissions.Experience with Class II and Class III medical devices.Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.Experience with post-approval manufacturing and design changesExperience leading or mentoring a team of regulatory affairs professionalsAbility to work effectively on cross-functional teams and build strong relationships with key stakeholdersStrong attention to detail with a solution-orientated mindset.Able to juggle multiple and competing priorities.Experience with exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business.Uses in-depth knowledge of business functions and cross group dependencies/ relationships.The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.