Senior Medical Writer

Masimo Corporation; Irvine (CA); On-site; USD 130,000 - 150,000; Full time

Job summary

Masimo Irvine, CA is seeking a Senior Medical Writer to develop clinical evaluation reports (CERs) and post-market surveillance (PMS) reports in compliance with EU MDR and global standards. You will lead literature reviews, appraise evidence, and collaborate with Scientific Affairs, Clinical Research, Regulatory Affairs, Engineering, and Marketing to support product portfolio compliance.

You will report to the Sr Director, Scientific Affairs & Research, and this is an on-site role in Irvine, CA.

Qualifications

• Demonstrated experience conducting systematic literature reviews and critical appraisals.
• Proven ability to interpret and summarize complex clinical information for technical and non-technical audiences.
• Experience managing scientific references and literature search platforms.
• Strong organizational skills and experience using reference management software.

Responsibilities

• Lead CER and PMS report development following EU MDR and global guidance.
• Design and execute systematic literature searches and maintain citation libraries.
• Interpret literature for clinical relevance and device claims.
• Prepare literature reviews, evidence summaries, and safety assessments.
• Monitor emerging literature relevant to Masimo products and technologies.
• Contribute to clinical study reports, white papers, and peer-reviewed manuscripts.

Skills

Systematic literature reviews

Critical literature appraisal

Scientific communication

Reference management

Tools

Reference management software

Job description

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 Syste m which makes everything possible.

The Senior Medical Writer is responsible forthe 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.

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

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 in:

• 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.

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 ofpossible compensationfor this role at the time of this posting. This range may bemodifiedin the future.

This job is also eligible for bonus pay.

We offercomprehensivepackage of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of payis considered to bewages 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.

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.

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.

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.

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 [e-mail].