Abbott
Global Head of Quality and Regulatory Affairs, Lingo
Abbott, Alameda, California, United States, 94501
Global Head of Quality and Regulatory Affairs, Lingo
Overview: Lingo is Abbott’s biowearables initiative focused on monitoring glucose and other metabolic biomarkers and integrating data with sleep, exercise, and stress to provide personalized health insights. We are seeking a Global Head of Quality and Regulatory Affairs to lead the strategic and operational global Quality and Regulatory Affairs (QARA) function for SaMD and related digital health offerings. This role reports to the Lingo Divisional VP and will drive the implementation of a best-in-class digital Quality Assurance and Compliance system, oversee global regulatory clearances, and manage successful commercial launches in LATAM, Europe, the Gulf, and Asia.
What You’ll Work On
QMS 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 with cross-functional teams (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.
Leadership Alignment: Act as a key member of the Lingo leadership team, ensuring alignment across functions and managing key stakeholders across Abbott.
Qualifications
Bachelor’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.
Deep understanding of QA principles, methodologies, and best practices for medical devices and SaMD; experience with AI/ML-enabled medical devices or digital health solutions is a plus.
Extensive knowledge of global regulatory requirements, including FDA (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 international markets.
Strong leadership and people management skills with experience building high-performing teams.
Excellent communication, interpersonal, and influencing skills.
Ability to operate effectively in a fast-paced, dynamic environment.
Regulatory Affairs Certification (RAC) preferred.
Abbott is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
For inquiries about the role or to apply, please refer to Abbott’s official careers page.
#J-18808-Ljbffr
What You’ll Work On
QMS 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 with cross-functional teams (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.
Leadership Alignment: Act as a key member of the Lingo leadership team, ensuring alignment across functions and managing key stakeholders across Abbott.
Qualifications
Bachelor’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.
Deep understanding of QA principles, methodologies, and best practices for medical devices and SaMD; experience with AI/ML-enabled medical devices or digital health solutions is a plus.
Extensive knowledge of global regulatory requirements, including FDA (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 international markets.
Strong leadership and people management skills with experience building high-performing teams.
Excellent communication, interpersonal, and influencing skills.
Ability to operate effectively in a fast-paced, dynamic environment.
Regulatory Affairs Certification (RAC) preferred.
Abbott is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
For inquiries about the role or to apply, please refer to Abbott’s official careers page.
#J-18808-Ljbffr