Senior Regulatory Affairs Manager - Digital Solutions (on-site)

Working at Abbott 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 of. Employees 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 contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A 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 Fortune. A 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 scientists. The Opportunity We are recruiting for a Senior Regulatory Affairs Manager to join our Digital Solutions team on-site in Sylmar, CA or Santa Clara, CA. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. Additionally, will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide. What You'll Work On Regulatory Strategy & Product Lifecycle Management Contribute to and execute global regulatory strategies supporting product development, registration, commercialization, and lifecycle management. Provide regulatory guidance to cross-functional teams on product development, clinical evaluation, manufacturing changes, and post-market activities. Assess regulatory risks, interpret evolving regulations, and recommend strategies to support business objectives and market access. Support regulatory due diligence activities related to acquisitions, partnerships, and business development opportunities. Regulatory Submissions & Agency Interactions Lead the preparation, review, and submission of regulatory filings to global health authorities. Ensure submission quality, manage agency reviews, and coordinate responses to regulatory inquiries. Serve as a primary regulatory contact with regulatory authorities to support product approvals, registrations, and market access. Support FDA, EU MDR/CE Mark, and other applicable global regulatory pathways, including Software as a Medical Device (SaMD). Regulatory Compliance & Product Safety Ensure compliance with applicable regulatory requirements, including FDA regulations, EU MDR, ISO 13485, and other regional requirements. Manage registrations, licenses, listings, certifications, and post-market regulatory obligations. Review labeling, promotional materials, and external communications for regulatory compliance. Provide regulatory oversight for adverse event reporting, field actions, recalls, and other product safety activities. Quality Systems & Continuous Improvement Partner with Quality to support and continuously improve the Quality Management System in compliance with applicable regulations and standards. Develop, implement, and maintain regulatory procedures, SOPs, and processes. Assess regulatory impact of product and quality system changes and ensure appropriate actions are implemented. Leadership & Cross-Functional Collaboration Manage, mentor, and develop regulatory affairs personnel. Serve as a regulatory subject matter expert and trusted partner to cross-functional teams. Lead regulatory projects and contribute to cross-functional initiatives requiring regulatory expertise. Promote a culture of compliance, collaboration, accountability, and continuous improvement. Required Qualifications Bachelor's Degree in a related field or an equivalent combination of education and experience 9 years' related work experience. Working within a quality management system (QMS) with a clear understanding of the product lifecycle management and activities. Understanding of, and ability to interpret and apply, relevant information related to domestic and international regulatory guidelines, policies and regulations. Supporting pre-market and post-market cross functional teams; developing and communicating global regulatory strategies for new product submissions or complex changes to on-market products. Assessing the regulatory impact of labeling, manufacturing and design changes for PMA approved products, 510(k) products and EU MDR certified products. Authoring PMA and/or IDE supplements, Pre-submissions, 510(k)s, EU substantial and non-substantial change notifications. Providing direction and monitoring progress of exempt specialists and/or non-exempt staff toward accomplishment of business and Regulatory Affairs goals. Mentoring and developing Regulatory Affairs specialists. Identifying process improvements and participating in development and execution of improvement activities. Working with Regulators and Notified bodies such as FDA and BSI during consultations, initial submissions, deficiency responses and approvals. Working knowledge of regulatory requirements for medical devices in other countries such as Canada, China, Japan, Australia, Brazil, etc. Preferred Qualifications Bachelor's degree in scientific or engineering related disciplines. Master's degree or additional professional training in regulatory affairs (such as RAC from the Regulatory Affairs Professionals Society.) 7 or more years of global regulatory submission experience, with substantial knowledge of US FDA Medical Device Regulatory Requirements for class II medical devices and EU Medical Device Regulations for new and on market devices. Experience working in Quality Assurance or Quality Management Systems. Experience working with medical devices for the treatment of heart disease. Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences. Ability to define regulatory strategy. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues. Think analytically with good problem-solving skills. Ability to work in a highly matrixed and geographically diverse environment. Has broad knowledge of various technical alternatives and their potential impact on the business. Abbott is an Equal Opportunity Employer, committed to employee diversity. The base pay for this position is $130,700.00 - $261,300.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr Socket.dev