New · posted Oct 16
Abbott · Medical Devices
Regulatory Affairs Specialist II – Vascular
- Temecula, CA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our Vascular Division team on-site in Temecula, CA. In this role, you will support EU and US regulatory activities and collaborate with the global regulatory organization to maintain regulatory compliance for a portfolio of endovascular medical devices used in the treatment of peripheral artery disease. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas to ensure regulatory considerations are integrated throughout the product lifecycle. Proven successful track record of preparing submissions and documentation in compliance with relevant medical device regulations is preferred.
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.), engineering, or biomedical fields.
- Master’s degree in Regulatory Affairs.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Experience within the medical device industry, particularly supporting Class II and/or Class III products.
- Experience supporting commercially marketed medical devices, including post-market compliance and regulatory maintenance activities.
- Experience authoring or supporting regulatory submissions and regulatory strategies that resulted in successful regulatory outcomes.
- Experience with U.S. regulatory submissions, including Traditional, Special, and Abbreviated 510(k)s, PMAs, and PMA supplements.
- Experience with EU MDR (2017/745) Technical Documentation and change assessments.
- Working knowledge of medical device regulations and international standards, including ISO 13485, and ISO 14971.
- Experience conducting regulatory assessments associated with design, manufacturing, supplier, labeling, and process changes.
- Experience with risk management activities and documentation in accordance with ISO 14971.
- Experience working within medical device quality systems and design control environments.
- Experience with electronic document management systems (EDMS), product lifecycle management (PLM) systems, and change control processes.
- Ability to work effectively in a highly matrixed and geographically diverse organization.
- Experience with cardiovascular, endovascular, peripheral vascular, implantable, catheter-based, or other complex medical device technologies is preferred.
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.
What you'll do
What You’ll Work On
- Evaluate regulatory impact and develop global regulatory strategies to support product lifecycle management activities.
- Prepare and support regulatory submissions for Vascular devices to achieve departmental and organizational objectives.
- Assess proposed product, manufacturing, supplier, process, and labeling changes to determine regulatory impact and submission requirements across global markets.
- Develop and document regulatory assessments supporting design control and change management activities.
- 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.
- Support maintenance of regulatory approvals and registrations for commercially marketed products.
- Support 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.
- 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
$61,300 – $122,700 a year
Employer providedThe base pay for this position is
$61,300.00 – $122,700.00
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
Temecula, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Temecula, CAWorking conditions
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
No
JOB FAMILY
Regulatory Operations
DIVISION
AVD Vascular
LOCATION
United States > Temecula : Building B - TB
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.
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
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 16, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Associate & Specialist roles in California14 roles publishing pay
Associate & Specialist roles in the US29 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $61,300 | — | $122,700 |
| California (middle half) | $87,875 | $91,750 | $95,375 |
| All US (middle half) | $78,000 | $91,500 | $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, October 16, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 295 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 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs7
- Regulatory submissions7
- Quality systems and risk7
- Collaboration and leadership6
- GMP and compliance4
- Lab testing and methods2
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.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- 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
Company hiring pulse
Abbott on Regulatory Jobs
- 81
- Open roles
- 75
- Distinct roles
- 32
- Locations
By discipline
- Quality54 67%
- Regulatory25 31%
- Compliance & Safety2 2%
By level
- Senior & Principal41 51%
- Associate & Specialist23 28%
- Manager14 17%
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Regulatory Affairs Specialist II – Vascular at Abbott
Open until filled. $61K–$123K a year, employer provided.