New · posted Oct 30
Abbott · Medical Devices
Regulatory Affairs Specialist II – Structural Heart
- Santa Clara, CA
- On-site
- Full-time
- Senior & Principal
The role
As an individual contributor, this position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval, ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for clinical trial operations and 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.
Structural Heart Business Mission: why we exist
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.
This Regulatory Affairs Specialist II will work on-site at our Santa Clara, CA location in our Abbott Structural Heart division to perform regulatory activities for a transcatheter heart valve replacement device.
What you need
Required Qualifications
- Bachelor’s Degree or an equivalent combination of education and work experience
- Minimum 3 years’ related experience, including a minimum of two years regulatory experience
- Experience with either 510(k) applications, IDE supplements, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage, manage and/or engage others to accomplish projects.
- Strong problem-solving skills and ability to think strategically and see the big picture.
- Adaptable with the ability to switch priorities and accomplish all tasks.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Strong organizational and follow-up skills, as well as attention to detail.
- Multitasks, prioritizes and meets deadlines in timely manner.
Preferred Qualificationsnice to have
- Bachelor’s Degree in a Science/Technical discipline (engineering, life sciences, mathematics).
- Master’s degree
- Experience with regulatory activities required for clinical trials.
- Experience working in a broader enterprise/cross-division business unit model.
- Experience working in the Medical Device industry.
- Regulatory Affairs Professionals Society Certification is a plus.
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.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
What you'll do
What You’ll Work On
- Prepares robust regulatory applications (either for FDA or for international regulatory agencies) to achieve departmental and organizational objectives.
- Creates, reviews and approves engineering changes.
- Reviews and provides input on device labeling.
- Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
- 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.
- May interface directly with FDA and other regulatory agencies.
- Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
- Reviews protocols and reports to support regulatory submissions.
- Supports all business segment initiatives as identified by divisional 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) and international regulations, 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.
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
Santa Clara, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Santa Clara, CAWorking conditions
Standard
TRAVEL
Yes, 5 % of the Time
MEDICAL SURVEILLANCE
No
JOB FAMILY
Regulatory Operations
DIVISION
SH Structural Heart
LOCATION
United States > Santa Clara : Building A - SC
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.
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 · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Senior & Principal roles in California18 roles publishing pay
Senior & Principal roles in the US52 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $81,500 | — | $141,300 |
| California (middle half) | $131,250 | $142,000 | $150,000 |
| All US (middle half) | $116,500 | $142,750 | $153,875 |
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, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 303 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 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Regulatory submissions5
- GMP and compliance3
- Documentation and SOPs3
- Clinical trial conduct3
- Quality systems and risk1
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.
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
- FDAFDA PMA(official source, opens in a new tab)Premarket approval for class III medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Abbott on Regulatory Jobs
- 91
- Open roles
- 83
- Distinct roles
- 30
- Locations
By discipline
- Quality60 66%
- Regulatory30 33%
By level
- Senior & Principal43 47%
- Associate & Specialist27 30%
- Manager17 19%
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Regulatory Affairs Specialist II – Structural Heart at Abbott
Open until filled. $82K–$141K a year, employer provided.