Abbott Laboratories
Global Head of Quality and Regulatory Affairs, Lingo
Abbott Laboratories, Alameda, California, United States, 94501
Abbott offers a dynamic and inclusive work environment, competitive compensation, and the opportunity to make a real difference in the lives of manyLingo 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. * **Digital-First QMS Leadership:** Design and implement a scalable, software-centric Quality Management System (QMS) optimized for Agile, DevOps, and CI/CD workflows, ensuring compliance with applicable regulatory requirements.* **Software Quality Assurance:** Define and enforce robust software quality standards across the development lifecycle, including validation, verification, risk management, cybersecurity, and documentation practices.* **Global Regulatory Strategy:** Develop and execute regulatory strategies for software-enabled medical devices, ensuring alignment with FDA, EMA, EU MDR, ISO 13485, and other relevant frameworks. Navigate the nuanced classification of Lingo’s app features across geographies.* **Market Expansion Leadership:** Lead regulatory efforts to support Lingo’s entry into global markets, including regions where the product may or may not be classified as a medical device.* **Audit & Compliance Oversight:** Drive internal audits, maintain software lifecycle documentation, and lead continuous improvement initiatives to ensure global compliance and readiness for regulatory inspections.* **Cross-Functional Collaboration:** Partner closely with R&D, software engineering, clinical, and product teams to embed quality and compliance into every stage of product development and iteration.* **Team Building & Leadership:** Build and mentor a high-performing QARA team with deep expertise in software quality, regulatory affairs, and medical device compliance.* **Post-Market Surveillance:** Oversee software-related complaint handling, CAPA processes, and real-world performance monitoring to ensure safety, effectiveness, and user satisfaction.**Qualifications** * Bachelor’s degree in engineering, computer science, or a related technical field.* 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 in a SaMD or software-intensive medical device company is essential.* Deep understanding of software quality assurance principles, including software validation, risk management, and lifecycle documentation.* Experience with AI/ML-enabled medical devices, digital health platforms, or connected 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 SaMD in international markets.* Strong leadership and people management skills, with experience building and developing high-performing teams.* Excellent communication, interpersonal, and influence skills.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 @AbbottGlobal #J-18808-Ljbffr
Your proven experience managing change and driving transformation in a fast-paced consumer and Med Tech landscape will be integral to our success. * **Digital-First QMS Leadership:** Design and implement a scalable, software-centric Quality Management System (QMS) optimized for Agile, DevOps, and CI/CD workflows, ensuring compliance with applicable regulatory requirements.* **Software Quality Assurance:** Define and enforce robust software quality standards across the development lifecycle, including validation, verification, risk management, cybersecurity, and documentation practices.* **Global Regulatory Strategy:** Develop and execute regulatory strategies for software-enabled medical devices, ensuring alignment with FDA, EMA, EU MDR, ISO 13485, and other relevant frameworks. Navigate the nuanced classification of Lingo’s app features across geographies.* **Market Expansion Leadership:** Lead regulatory efforts to support Lingo’s entry into global markets, including regions where the product may or may not be classified as a medical device.* **Audit & Compliance Oversight:** Drive internal audits, maintain software lifecycle documentation, and lead continuous improvement initiatives to ensure global compliance and readiness for regulatory inspections.* **Cross-Functional Collaboration:** Partner closely with R&D, software engineering, clinical, and product teams to embed quality and compliance into every stage of product development and iteration.* **Team Building & Leadership:** Build and mentor a high-performing QARA team with deep expertise in software quality, regulatory affairs, and medical device compliance.* **Post-Market Surveillance:** Oversee software-related complaint handling, CAPA processes, and real-world performance monitoring to ensure safety, effectiveness, and user satisfaction.**Qualifications** * Bachelor’s degree in engineering, computer science, or a related technical field.* 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 in a SaMD or software-intensive medical device company is essential.* Deep understanding of software quality assurance principles, including software validation, risk management, and lifecycle documentation.* Experience with AI/ML-enabled medical devices, digital health platforms, or connected 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 SaMD in international markets.* Strong leadership and people management skills, with experience building and developing high-performing teams.* Excellent communication, interpersonal, and influence skills.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 @AbbottGlobal #J-18808-Ljbffr