Global Head of Quality and Regulatory Affairs, Lingo - Abbott Laboratories : Job Details

Working at Abbott

At Abbott, you can do work that matters, grow, and 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 the career you dream of

• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

• An excellent retirement savings plan with high employer contribution

• A company recognized as

  a great place

  to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune

• Abbott

  offers a dynamic and inclusive work environment, competitive compensation, and the opportunity to make a real difference in the lives of many

About Lingo

Abbott's rich history in developing

cutting-edge

health technologies is evolving with its new venture into

b

iowearables

. The

b

iowearables

segment is poised to

represent

the future of the organization, with the potential to generate over

$1

billion

in revenue within the next five years, supported by Abbott's robust R&D and financial resources.

At Lingo, we are committed to transforming health management with our

cutting-edge

biowearables

that

monitor

glucose levels and

other

critical metabolic biomarkers. Our products integrate seamlessly with

other

health indicators such as sleep, exercise, and stress, to

provide

personalized insights that improve metabolic well-being. This is your opportunity to be at the forefront of health innovation and make a significant impact on people's lives

The Opportunity

Lingo is seeking a

n

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.

Th

is 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/inspectionalagencies.

Leading a dynamic team of

20+

Quality and

R

egulatory 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.

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 effectively with cross-functional teams (e.g., 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.

• A k

  ey m

  ember of

  the

  Lingo leadership team

  ensuring alignment across all 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 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, dynamicenvironment.

• 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

APPLY NOW

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

www.abbottbenefits.com

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

www.abbott.com

www.facebook.com/Abbott

The base pay for this position is $193,300.00 – $386,700.00. In specific locations, the pay range may vary from the range posted.