Global Head of Quality and Regulatory Affairs, Lingo at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Proven experience managing change and driving transformation in a fast-paced consumer and Med Tech landscape
Experience leading the implementation of a best-in-class digital Quality Assurance and Compliance system optimized for Software as Medical Device (SaMD)
Expertise in developing and executing global regulatory strategies and roadmaps for product submissions and clearances across diverse markets (e.g., LATAM, Europe, Gulf Countries, Asia)
Knowledge of global regulatory standards (e.g., FDA, EMA, ISO 13485, EU MDR)
Ability to lead regulatory activities for commercial launches in 20+ markets, navigating complex regional regulations
Experience overseeing all aspects of quality and regulatory affairs, from design and development to post-market surveillance
Capability to serve as Management Representative for the division with regulatory/inspectional agencies
Leadership experience managing and inspiring a dynamic team of 20+ Quality and Regulatory professionals

Responsibilities

Lead the innovative biowearables initiative and drive the next phase of growth in consumer health technology, reporting directly to the Lingo Divisional VP
Design, implement, and continuously improve a robust, scalable digital Quality Management System (QMS) tailored for Software as a Medical Device (SaMD) in a regulated environment
Develop and execute global regulatory strategies and roadmaps for product submissions and clearances across diverse markets
Lead regulatory activities for launching Lingo in 20 markets across LATAM, Europe, Gulf Countries, and Asia
Ensure compliance with global regulatory standards (e.g., FDA, EMA, ISO 13485, EU MDR) and oversee internal and external audits
Oversee all aspects of quality and regulatory affairs, from design and development to post-market surveillance
Serve as the Management Representative for the division with regulatory/inspectional agencies
Lead, develop, grow, and inspire a team of 20+ Quality and Regulatory professionals to meet short-term and long-term business objectives

Skills

Regulatory Affairs

Quality Assurance

Medical Devices

FDA Regulations

ISO 13485

GMP

Risk Management

Compliance

Biowearables

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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