Global Head of Quality and Regulatory Affairs, Lingo

Abbott

  • Alameda, CA
  • Permanent
  • Full-time
  • 21 hours ago
Abbott 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 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 ofFree medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent retirement savings plan with high employer contributionA 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 FortuneAbbott offers a dynamic and inclusive work environment, competitive compensation, and the opportunity to make a real difference in the lives of manyAbout LingoAbbott's rich history in developing cutting-edge health technologies is evolving with its new venture into biowearables. The biowearables segment is poised to represent the future of the organization, with the potential to generate over $1 billion in revenue within the next five years, supported by Abbott’s robust R&D and financial resources.At Lingo, we are committed to transforming health management with our cutting-edge biowearables that monitor glucose levels and other critical metabolic biomarkers. Our products integrate seamlessly with other health indicators such as sleep, exercise, and stress, to provide personalized insights that improve metabolic well-being. This is your opportunity to be at the forefront of health innovation and make a significant impact on people’s lives.The OpportunityLingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative and drive the next phase of our growth in consumer health technology. This role is a strategic leadership position reporting directly to the Lingo Divisional VP. This individual will lead the implementation of a best-in-class digital Quality Assurance and Compliance system optimized for Software as Medical Device. In addition, this individual will play a pivotal role in Lingo's global expansion, leading efforts to achieve successful regulatory clearances and commercial launches in LATAM, Europe, Gulf Countries, and Asia.Overseeing all aspects of quality and regulatory affairs, from design and development to post-market surveillance, this role ensures Lingo meets the highest standards for safety, efficacy, and compliance. This person will serve as the Management Representative for the division with regulatory/inspectional agencies.Leading a dynamic team of 20+ Quality and Regulatory professionals, you'll continue to develop, grow, and inspire the team to meet short-term and long-term objectives of the business. Your proven experience managing change and driving transformation in a fast-paced consumer and Med Tech landscape will be integral to our success.What You'll Work OnQMS Leadership: Design, implement, and continuously improve a robust, scalable digital QMS tailored for Software as a Medical Device (SaMD) in a regulated environment.Regulatory Strategy: Develop and execute global regulatory strategies and roadmaps for product submissions and clearances across diverse markets.Market Expansion: Lead regulatory activities for launching Lingo in 20 markets across LATAM, Europe, Gulf Countries, and Asia, navigating complex regional regulations.Compliance and Oversight: Ensure compliance with global regulatory standards (e.g., FDA, EMA, ISO 13485, EU MDR) and oversee internal and external audits.Documentation and Submissions: Manage the preparation and submission of regulatory dossiers, including technical files, design control documentation, and post-market surveillance reports.Stakeholder Collaboration: Partner effectively with cross-functional teams (e.g., R&D, product, clinical, marketing) to integrate quality and regulatory considerations throughout the product lifecycle.Team Management: Build and lead a high-performing QARA team, fostering a culture of quality-first and regulatory excellence.Post-Market Surveillance: Oversee post-market surveillance, complaint handling, and CAPA processes to ensure ongoing compliance and continuous product improvement.A key member of the Lingo leadership team, ensuring alignment across all functions and managing key stakeholders across AbbottQualificationsBachelor's degree in a relevant scientific or technical field (e.g., engineering, life sciences).MS, MBA or PhD preferred.10+ years of experience in Quality Management Systems within a regulated industry, with at least 5 years in a leadership role.Proven experience implementing and managing a digital QMS within a SaMD company is essential.Deep understanding of quality assurance principles, methodologies, and best practices relevant to medical devices and SaMD. Experience with AI/ML-enabled medical devices or digital health solutions.Extensive knowledge of global regulatory requirements, including FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and EU MDR/IVDR.Successful track record of preparing and submitting regulatory dossiers for medical devices, particularly SaMD, in various international markets.Strong leadership and people management skills, with experience building and developing high-performing teams.Excellent communication, interpersonal, and influence skills.Ability to work effectively in a fast-paced, dynamic environment.Regulatory Affairs Certification (RAC) preferred.If you're excited about the opportunity to lead innovation in health technology and help shape the future of personal health management, we would love to hear from you.Together, let’s create products that empower individuals and redefine self-care.Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobalThe base pay for this position is $193,300.00 – $386,700.00In specific locations, the pay range may vary from the range posted.JOB FAMILY: Operations QualityDIVISION: LNGO LingoLOCATION: United States
Alameda : 2901 Harbor Bay ParkwayADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 25 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott