Abbott
Global Head of Quality and Regulatory Affairs, Lingo
Abbott, Alameda, California, United States, 94501
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
All candidates should make sure to read the following job description and information carefully before applying. Job Description
Working at Abbott At Abbott, you can do work that matters, grow, 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 your dream career Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contributions A company recognized as a great place to work globally and named one of the most admired companies in the world by Fortune Dynamic and inclusive work environment, competitive compensation, and the opportunity to make a difference About Lingo Abbott's history in developing health technologies is evolving with its new venture into biowearables. The biowearables segment aims to be a future pillar of the organization, with potential revenues over $1 billion in five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with biowearables that monitor glucose and other metabolic biomarkers, integrating with health indicators like sleep, exercise, and stress to provide personalized insights for better metabolic health. This is your chance to be at the forefront of health innovation and impact lives. The Opportunity Lingo seeks a
Global Head of Quality and Regulatory Affairs
to lead our biowearables initiative and drive growth in consumer health technology. This strategic leadership role reports to the Lingo Divisional VP and involves implementing a digital Quality Assurance and Compliance system for Software as Medical Device (SaMD). The role also includes leading regulatory approvals and product launches in LATAM, Europe, Gulf Countries, and Asia. Responsibilities include overseeing all aspects of quality and regulatory affairs, serving as the Management Representative, leading a team of 20+ professionals, and managing change and transformation in a fast-paced environment. Key Responsibilities
Design and improve a digital QMS for SaMD Develop and execute global regulatory strategies Lead regulatory activities for market expansion across multiple regions Ensure compliance with global standards (FDA, EMA, ISO 13485, EU MDR) Manage regulatory documentation and submissions Collaborate with cross-functional teams Build and lead a high-performing team Oversee post-market surveillance and CAPA processes Align with leadership and manage stakeholder relationships Qualifications
Bachelor's in a scientific or technical field; MS, MBA, or PhD preferred 10+ years in Quality Management Systems, with 5+ years in leadership Experience implementing digital QMS for SaMD Deep knowledge of quality assurance and global regulatory requirements Proven track record in regulatory submissions for medical devices Strong leadership and communication skills Regulatory Affairs Certification (RAC) preferred If you're excited about leading innovation in health technology, we want to hear from you. Join us to create products that empower and redefine self-care. APPLY NOW Learn more about our benefits at www.abbottbenefits.com. Follow your career aspirations with Abbott, a diverse and inclusive employer. Connect with us at www.abbott.com, Facebook, and Twitter. Salary Range:
$193,300 - $386,700 (may vary by location) Job Details:
Operations Quality, LNGO Lingo, United States - Alameda, 25% travel, standard shift Abbott is an Equal Opportunity Employer. EEO is the Law: English, Spanish.
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All candidates should make sure to read the following job description and information carefully before applying. Job Description
Working at Abbott At Abbott, you can do work that matters, grow, 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 your dream career Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contributions A company recognized as a great place to work globally and named one of the most admired companies in the world by Fortune Dynamic and inclusive work environment, competitive compensation, and the opportunity to make a difference About Lingo Abbott's history in developing health technologies is evolving with its new venture into biowearables. The biowearables segment aims to be a future pillar of the organization, with potential revenues over $1 billion in five years, supported by Abbott’s robust R&D and financial resources. At Lingo, we are committed to transforming health management with biowearables that monitor glucose and other metabolic biomarkers, integrating with health indicators like sleep, exercise, and stress to provide personalized insights for better metabolic health. This is your chance to be at the forefront of health innovation and impact lives. The Opportunity Lingo seeks a
Global Head of Quality and Regulatory Affairs
to lead our biowearables initiative and drive growth in consumer health technology. This strategic leadership role reports to the Lingo Divisional VP and involves implementing a digital Quality Assurance and Compliance system for Software as Medical Device (SaMD). The role also includes leading regulatory approvals and product launches in LATAM, Europe, Gulf Countries, and Asia. Responsibilities include overseeing all aspects of quality and regulatory affairs, serving as the Management Representative, leading a team of 20+ professionals, and managing change and transformation in a fast-paced environment. Key Responsibilities
Design and improve a digital QMS for SaMD Develop and execute global regulatory strategies Lead regulatory activities for market expansion across multiple regions Ensure compliance with global standards (FDA, EMA, ISO 13485, EU MDR) Manage regulatory documentation and submissions Collaborate with cross-functional teams Build and lead a high-performing team Oversee post-market surveillance and CAPA processes Align with leadership and manage stakeholder relationships Qualifications
Bachelor's in a scientific or technical field; MS, MBA, or PhD preferred 10+ years in Quality Management Systems, with 5+ years in leadership Experience implementing digital QMS for SaMD Deep knowledge of quality assurance and global regulatory requirements Proven track record in regulatory submissions for medical devices Strong leadership and communication skills Regulatory Affairs Certification (RAC) preferred If you're excited about leading innovation in health technology, we want to hear from you. Join us to create products that empower and redefine self-care. APPLY NOW Learn more about our benefits at www.abbottbenefits.com. Follow your career aspirations with Abbott, a diverse and inclusive employer. Connect with us at www.abbott.com, Facebook, and Twitter. Salary Range:
$193,300 - $386,700 (may vary by location) Job Details:
Operations Quality, LNGO Lingo, United States - Alameda, 25% travel, standard shift Abbott is an Equal Opportunity Employer. EEO is the Law: English, Spanish.
#J-18808-Ljbffr