Job Details

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. **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 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 @AbbottGlobal#J-18808-Ljbffr