A

Abbott

Makes heart devices, glucose sensors and lab tests

Regulatory Affairs Specialist 3 - Diabetes Care

Full-TimeUpdated on 10/23/2026
$68k - $136k
Senior
Bachelor's
Buffalo Grove, IL, USA
In PersonOn-site in Buffalo Grove; travel 5% of the time.
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A bachelor's degree or an equivalent combination of education and experience is required.
  • Five years of work experience is required.
  • A bachelor's degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, or engineering is preferred.
  • Five or more years of experience in the medical device industry is preferred.
  • One to two years of regulatory experience is preferred.
  • Ability to communicate effectively and prepare and negotiate with internal and external stakeholders, including regulatory agencies, is preferred.
  • Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues is preferred.
  • Analytical thinking and problem-solving skills are preferred.
  • Experience with 510(k), PMA, or other international regulatory submissions is preferred.
  • RAPS certification is preferred.
Responsibilities
  • Verify regulatory requirements with supervisory staff and execute them in relation to product development, submissions, product maintenance, and project plans.
  • Provide technical leadership and strategic input on complex issues to business units.
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle, and develop solutions with regulatory and related teams.
  • Develop global regulatory strategies for product development and planning throughout the product lifecycle.
  • Analyze regulatory outcomes against initial product concepts and recommend future strategies and actions.
  • Implement the Division Regulatory Strategy in specific product-related activities.
  • Obtain supervisory input to interpret requirements and resolve issues related to product development and support.
  • Analyze cumulative product changes for their impact on current product submissions.
  • Lead functional groups in developing relevant data to complete regulatory submissions.
  • Follow through on submission-related activities to secure product approval.
  • Share knowledge with colleagues in the department and on teams.
  • Establish and execute project goals and implement plans.
  • Provide input to the establishment and implementation of group plans.
  • Follow Good Manufacturing Practice (GMP) guidelines and procedures.
  • Prepare clear and concise written information for varying target audiences.
  • Implement and maintain the effectiveness of the quality system.
  • Administer and meet regulatory requirements to achieve compliance without enforcement actions.
  • Advise and communicate basic regulatory strategies to project, group, or venture teams for division-wide products.
  • Sign off at team level within delegated parameters for change control.
  • Direct daily activities using team goals and division regulatory priorities.
  • Support Regulatory Affairs management in resolving compliance issues in accordance with site and division policies and procedures and the appropriate quality system.
  • Obtain supervisory regulatory review of submission documents before submitting them to government agencies.

About the company

A

Abbott

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Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company Size

10,001+

Company Stage

IPO

Headquarters

North Chicago, Illinois

Founded

1888

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Simplify's Take

What believers are saying

  • Devices carry the growth: Abbott's device sales rose 8.4% on a comparable basis from April to June 2026.
  • Diabetes teams get a launch to build: FDA authorized Libre Duo, the first glucose and ketone sensor, in August 2026.
  • Abbott bought a cancer screening business: its roughly $21 billion Exact Sciences purchase closed in March 2026.

What critics are saying

  • Formula lawsuits linger: after a $670 million August 2026 settlement, about 1,700 suits over preemie formula remain.
  • Nutrition staff sit in a shrinking unit: Abbott's nutrition sales fell 3.6% comparably from April to June 2026.
  • Abbott's top product drew a severe recall: FDA flagged Libre 3 sensor errors linked to seven deaths in January 2026.

What makes Abbott unique

  • Abbott's drug arm skips the US: it sells branded generic medicines only in markets such as India and Latin America.
  • Abbott sells to grocery shoppers too: Similac formula and Ensure shakes sit on store shelves, unlike device rivals.
  • Abbott's heart implant reports to patients: CardioMEMS lets heart failure patients read their own artery pressure on phones.

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Benefits

  • Health Insurance
  • 401(k) Retirement Plan
  • 401(k) Company Match
  • Flexible Work Hours
  • Remote Work Options
  • Paid Vacation
  • Paid Sick Leave
  • Paid Holidays
  • Professional Development Budget
  • Wellness Program

Growth & Insights and Company News

6 month growth

-4%

1 year growth

7%

2 year growth

7%
Yahoo Finance
Oct 21st, 2026
Abbott to spin off $8.5B nutrition business, with Similac and Pedialyte, by end of 2027

Abbott Laboratories plans to spin off its nutrition business into an independent company with about $8.5 billion in annual sales. Shares fell 3.9% to $98.44 in premarket trading. Daniel Salvadori, an executive vice president, will lead the new company, which will house the Pedialyte and Similac brands. Abbott shareholders would own shares in both companies. Abbott expects to complete the separation by the end of 2027. Afterwards, it would have sales of about $42 billion, focused on medical devices, diagnostics, and established medicines. The company has faced years of litigation over a baby-formula facility, including a $385 million settlement in September and a $670 million settlement in August.

PR Newswire
Oct 21st, 2026
Abbott Q3 sales rise 14.5% to $13B, adjusted EPS $1.42; full-year guidance narrowed

Abbott reported third-quarter 2026 sales of $13,013 million, up 14.5% on a reported basis and 7.0% on a comparable basis. GAAP diluted earnings per share (EPS) were $0.53; adjusted diluted EPS were $1.42. The company expects full-year comparable sales growth of about 6.0%. It reaffirmed the midpoint of its adjusted diluted EPS guidance and tightened the range to $5.50 to $5.55. Diagnostics sales rose 46.7% to $3,305 million, helped by the March 23 acquisition of Exact Sciences. Medical Devices sales reached $5,826 million, up 6.9%, and Nutrition sales rose 5.1% to $2,262 million. Abbott won approvals for Libre Duo, a glucose-ketone sensor, and the TactiFlex Duo ablation catheter. It also launched SimpleScreen CRC, a blood-based colorectal cancer test.

PR Newswire
Oct 20th, 2026
Abbott's Cologuard Plus wins CE Mark for noninvasive colorectal cancer screening in Europe

Abbott's Cologuard Plus, a noninvasive stool-based test for colorectal cancer, has received CE Mark under the European Union's In Vitro Diagnostic Medical Devices Regulation. The approval is a step toward launching the test in Europe. Abbott plans to introduce it in select European markets, with timing varying by country based on local healthcare pathways, reimbursement and operational readiness. In the BLUE-C study of more than 20,000 participants, the test showed 95% sensitivity for colorectal cancer at 94% specificity. It cut false positives by up to 40% compared with the original Cologuard. About 538,000 people in Europe were diagnosed with colorectal cancer in 2022. Screening participation in reporting EU countries averaged 42%.

Yahoo Finance
Oct 15th, 2026
Chef Kardea Brown reimagines comfort food for husband's Type 2 diabetes with glucose tech

Chef and TV host Kardea Brown has reworked her recipes since her husband, Bryon Smith, was diagnosed with Type 2 diabetes at age 38. "It didn't mean the end of the foods we love," she said. The couple uses Abbott's FreeStyle Libre 3 Plus sensor with Libre Assist, a feature in the Libre app. It gives real-time glucose insights and predicts how a food may affect glucose levels before a meal. Smith snaps a photo of a dish and the app suggests healthier swaps. Brown advises building balanced meals with non-starchy vegetables, lean proteins, and healthy carbs. She also suggests reading labels for added sugar, eating more fibre, cooking simply at home, and planning meals ahead.

Philippines Graphic
Oct 15th, 2026
Abbott brings fast learning to life at its Fast Learners Field Day.

Abbott brings fast learning to life at its Fast Learners Field Day. October 15, 2026 VIA GRAPHIC PLUS | MANILA, Philippines (October 10, 2026) - Abbott hosted its Fast Learners Field Day to equip parents with practical insights on nutrition, child development and the importance of building strong foundations for learning. The event brought together families for interactive activities, learning experiences and an expert-led forum. The education-based forum highlighted how the right nutritional support helps children stay active and engaged, enabling them to make the most out of everyday learning opportunities during their formative years. Recognizing that every child's developmental journey is unique, experts emphasized that supporting a child's ability to learn goes beyond cognitive development alone. Gut health also plays a vital role through the important connection between the gut and brain. "A healthy tummy does more than support digestion," said Dr. Gamaliel Tayao, head of medical affairs for Abbott's nutrition business in the Philippines. "It also sends positive signals to the brain that can support mood, behavior, immunity and even learning. This is why Abbott pioneered research on special prebiotics called Human Milk Oligosaccharides (HMOs) in milk formulas to help support a healthy gut, strengthen immunity and nurture the gut-brain connection." Abbott's research has found children who consumed formula with five HMOs experienced 40% fewer healthcare visits and an average of 3.4 fewer sick days than children who did not receive HMO-enriched formula. These children also showed stronger language and social development, with 38% more imitating words as they began to speak and 24% more understanding everyday phrases compared with those who did not receive five-HMO formula. These differences reflect early communication behaviors considered important foundations for learning. Supporting every child's unique learning journey At the Fast Learners Field Day, parents and children explored the Fast Learner Trails, a series of interactive activity stations designed to showcase the building blocks that help children learn, grow and thrive. At the first station, children tackled creative challenges that encouraged problem-solving, imagination and confidence, reinforcing the importance of giving young minds opportunities to explore, discover and learn through play. This activity was powered by Similac GainSchool, which highlighted how nutrition with added gangliosides supports faster brain connections, helping children stay ready to learn every day. The second station demonstrated how a healthy tummy helps children stay comfortable, engaged and focused, allowing them to make the most of everyday learning experiences. Powered by Similac TummiCare HW, this station introduced families to the formula's unique Triple Comfort Blend that includes partially hydrolyzed whey protein, which helps reduce allergy risk and relieves tummy troubles. At the third station, parents learned that a child's nutritional needs can also be influenced by how their journey begins. Children born via C-section may have fewer beneficial gut bacteria due to missed exposure to microbes typically acquired during normal delivery. This can affect early immune development and may call for more targeted nutritional support. For moms of C-section-born children, Similac Essencia+ is enriched with immunity-supporting nutrients, including Abbott's highest levels of five HMOs, BB-12 probiotics and nucleotides that help promote the growth of good bacteria in the gut, supporting immune health during a critical stage of development. "Understanding how nutrition supports gut health and immunity can help parents give their children the foundation they need to participate fully in the experiences that shape their cognitive development," said Dr. Tayao. "Learning happens every day, whether children are solving problems, exploring their surroundings or interacting with others. To make the most of these opportunities, children need strong nutritional support to help nurture both their physical and cognitive development." Backed by science, trusted by families Parents play a vital role in nurturing their children's cognitive development by encouraging curiosity, supporting their interests and creating opportunities for exploration and discovery. Supported by proper nutrition, these everyday experiences help children build the confidence and resilience to become fast learners. Backed by more than 100 years of pediatric nutrition expertise and decades of HMO research, Abbott continues to support parents with science-based nutritional solutions through its range of Similac products, which are formulated to address children's unique needs at every stage of development. Started in 1927, the Philippines Graphic is the longest-running printed magazine of national circulation that provides relevant news and features and promotes Philippine literature.