New · posted Nov 1
Abbott · Medical Devices
Regulatory Affairs Specialist II – Lingo
- Alameda, CA
- On-site
- Full-time
- Associate & Specialist
The role
Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Alameda, CA. In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.
What you need
Required Qualifications
- Bachelor’s degree (or equivalent)
- 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
- Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Preferred Qualificationsnice to have
- Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields.
- Master’s degree in Regulatory Affairs.
- Regulatory experience with capital equipment including software, firmware, graphical user interfaces, and associated hardware.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society) .
What you'll do
What You’ll Work On
- Preparation of regulatory submissions for devices to achieve departmental and organizational objectives.
- Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities.
- Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
- Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
- Maintains pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested.
- Supports the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers.
- Collaborate with marketing team in review and approval of advertising and promotional materials.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities as assigned.
Pay and benefits
$81,500 – $141,300 a year
Employer providedThe base pay for this position is
$81,500.00 – $141,300.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage through Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Alameda, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Alameda, CAWorking conditions
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
No
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
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
JOB FAMILY
Regulatory Operations
DIVISION
LNGO Lingo
LOCATION
United States > Alameda : 2901 Harbor Bay Parkway
From the posting
About Abbott
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
- 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.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
ABOUT LINGO
Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers – such as glucose, ketones, and lactate – to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
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.
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 21% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Associate & Specialist roles in California13 roles publishing pay
Associate & Specialist roles in the US33 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $81,500 | — | $141,300 |
| California (middle half) | $87,500 | $91,500 | $95,500 |
| All US (middle half) | $84,000 | $92,000 | $95,000 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 298 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 20 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Documentation and SOPs3
- Regulatory submissions3
- GMP and compliance2
- Lab testing and methods1
- Quality systems and risk1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Abbott on Regulatory Jobs
- 108
- Open roles
- 98
- Distinct roles
- 32
- Locations
By discipline
- Quality61 56%
- Regulatory30 28%
- Clinical16 15%
By level
- Senior & Principal50 46%
- Associate & Specialist33 31%
- Manager21 19%
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Regulatory Affairs Specialist II – Lingo at Abbott
Open until filled. $82K–$141K a year, employer provided.