New · posted Nov 5
Danaher · Medical Devices
Regulatory Affairs Specialist
- Irvine, CA
- On-site
- Full-time
- Associate & Specialist
The role
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Masimo, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others.
Learn about the Danaher Business System which makes everything possible.
The Regulatory Affairs Specialist is responsible for obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual will be capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory requirements to future products to ensure compliance of the product to pre-market regulatory clearances.
This position reports to the Director, Regulatory Affairs and is part of the Regulatory Affairs team located in Irvine, CA and will be an on-site role.
What you need
The essential requirements of the job include
- 2+ years of work experience in a medical device Class II/ III environment.
- Bachelor’s degree is required, preferably in Engineering or Life Sciences.
- Excellent documentation skills including record maintenance/ tracking and understand document traceability.
It would be a plus if you also possess previous experience innice to have
- Regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.
- FDA/GMP requirements for medical device.
- Quality Systems per ISO 13485.
- Graduate Degree
Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
What you'll do
In this role, you will have the opportunity to
- Support the regulatory team managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, technical files, STED Documents and related submissions.
- Coordinate with regional regulatory team members on product changes and regulatory notification / approval requirements.
- Assist in communications with regional regulatory representatives to assist in filings and responses to inquiries from health authorities and notified bodies worldwide.
Pay and benefits
$80,000 – $100,000 a year
Employer providedBonus / Incentive Pay
10% of annual base salary
This job is also eligible for bonus / incentive pay. This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions.
This job is also eligible for a comprehensive package of benefits. Details regarding these benefits will be provided separately.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
The U.S. EEO posters are available here.
For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.
The annual salary range for this role is $80,000 - $100,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
Paid time off
Medical/dental/vision insurance
401(k)
10%
Bonus/incentive pay (10% of base salary)
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesDanaher's statements, word for word
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with 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 US27 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $80,000 | — | $100,000 |
| California (middle half) | $89,000 | $91,500 | $95,500 |
| All US (middle half) | $84,000 | $90,000 | $95,000 |
This role: Danaher's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 179 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Danaher's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership5
- Documentation and SOPs3
- Regulatory submissions3
- GMP and compliance2
- Quality systems and risk2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Affairs work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed deviceNamed in the posting
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDA21 CFR Part 814(official source, opens in a new tab)Premarket approval of class III medical devices
- FDAFDA De Novo(official source, opens in a new tab)Classification requests for novel low- to moderate-risk devices
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDAFDA eSTAR(official source, opens in a new tab)The electronic submission template for 510(k) and De Novo requests
- EUEU IVDR (Regulation 2017/746)(official source, opens in a new tab)The EU In Vitro Diagnostic Medical Devices Regulation
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
- FDA21 CFR Part 801(official source, opens in a new tab)FDA labeling requirements for medical devices
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- Health CanadaCanada Medical Devices Regulations(official source, opens in a new tab)Health Canada's licensing and quality requirements for medical devices (SOR/98-282)
Company hiring pulse
Danaher on Regulatory Jobs
- 60
- Open roles
- 50
- Distinct roles
- 20
- Locations
By discipline
- Quality50 83%
- Regulatory7 12%
- Clinical3 5%
By level
- Senior & Principal28 47%
- Associate & Specialist22 37%
- Manager8 13%
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Regulatory Affairs Specialist at Danaher
Open until filled. $80K–$100K a year, employer provided.