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New · posted Nov 1

Danaher · Medical Devices

Senior Medical Writer

  • Irvine, CA
  • On-site
  • Full-time
  • Senior & Principal
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EmploymentFull-time
DeadlineOpen until filled

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 Senior Medical Writer is responsible for the development of clinical evaluation reports (CERs) and post-market surveillance (PMS) reports in compliance with EU MDR and global regulatory standards. This role conducts systematic literature searches, appraises scientific evidence, and collaborates cross-functionally across Scientific Affairs, Clinical Research, Regulatory Affairs, Engineering, and Marketing to support product portfolio compliance and clinical communications.

This position reports to the Sr Director, Scientific Affairs & Research and is part of Medical Affairs located in Irvine, CA and will be an on-site role.

What you need

The essential requirements of the job include

·         ​​Demonstrated experience conducting systematic literature reviews and critical appraisals of scientific literature.

·         ​Proven ability to interpret and summarize complex clinical and scientific information for technical and non-technical audiences.

·         ​Experience managing scientific references and literature search platforms.

·         ​Strong organizational skills and experience using reference management software.​

It would be a plus if you also possess previous experience innice to have

  • ​​Direct experience authoring EU MDR-compliant CERs and PMS reports for medical devices.
  • ​Working knowledge of EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 14155, and FDA clinical guidance documents.
  • ​Proven track record of scientific publication in peer-reviewed journals

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.

This job is also eligible for bonus 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

·         Lead the development, maintenance, and periodic updates of CERs and PMS evaluation summaries in accordance with EU MDR, MEDDEV 2.7/1 Rev. 4 and global regulatory guidance.

·         Design, execute, and document systematic literature searches and screening strategies, while maintaining scientific reference libraries and ensure accurate citation and documentation of supporting evidence.

·         Critically appraise scientific literature for quality, clinical relevance, and alignment with intended device claims.

·         Interpret clinical study protocols, statistical analysis plans, and study results to incorporate into clinical evidence summaries.

·         Prepare literature review reports, evidence summaries, state-of-the-art analyses, clinical data appraisals, and benefit-risk assessments,

·         Monitor emerging scientific literature and technological developments relevant to Masimo products, therapeutic areas, and competitive technologies.

·         Contribute to clinical study reports, white papers, conference abstracts, posters and scientific manuscripts for peer-reviewed journals

Pay and benefits

$130,000 – $150,000 a year

Employer provided
How this compares

Bonus / 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.

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 $130,000-$150,000 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.

  • Health care program

  • Paid time off

  • Medical/dental/vision insurance

  • 401(k)

  • Bonus pay eligibility

Where you'll work

Irvine, CAOn-siteOpen in Maps (opens in a new tab)

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Equal 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 1, 2026

Salary intelligence

How the pay compares

This role's midpoint is 4% below the US median for Clinical Evaluation & Medical Writing roles at this level.

This roleEmployer provided

$130,000 to $150,000 a year

Senior & Principal roles in California5 roles publishing pay

Middle half $135,000 to $207,500, median $140,000

Senior & Principal roles in the US12 roles publishing pay

Middle half $131,125 to $178,500, median $146,000
Annual base pay
Annual base payLowMedianHigh
This role$130,000—$150,000
California$135,000$140,000$207,500
All US$131,125$146,000$178,500

This role: Danaher's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Clinical Evaluation & Medical Writing

The general path across 39 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Danaher's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Clinical Scientist Intern · Medical Writer

  2. This role

    Senior & Principal

    Often: Senior Medical Writer · Principal Medical Writer

    $146K median18 open
  3. Next step

    Manager

    Often: Manager, Medical Writing, Immunology · Medical Writing Manager

    $150K median5 open
  4. Later

    Director

    Often: Associate Director, Medical Writing · Director, Medical Writing

    $210K median13 open

Skills DNA

What this role leans on

How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 1 lineDocumentation and SOPs: 8 linesRegulatory submissions: 4 linesQuality systems and risk: 2 linesData and digital systems: 1 lineClinical trial conduct: 3 linesCollaboration and leadership: 3 linesGMPDocumentationSubmissionsQuality systemsData systemsClinical trialsTeamwork
  • Documentation and SOPs8
  • Regulatory submissions4
  • Clinical trial conduct3
  • Collaboration and leadership3
  • Quality systems and risk2
  • GMP and compliance1
  • Data and digital systems1

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.

Company hiring pulse

Danaher on Regulatory Jobs

60
Open roles
51
Distinct roles
19
Locations

By discipline

  • Quality52 87%
  • Regulatory5 8%
  • Clinical3 5%

By level

  • Senior & Principal28 47%
  • Associate & Specialist23 38%
  • Manager7 12%
See all 60 Danaher roles

More roles at Danaher

All 60 Danaher roles

Similar Clinical Evaluation & Medical Writing roles elsewhere

Senior Medical Writer at Danaher

Open until filled. $130K–$150K a year, employer provided.

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