Senior Medical Writer

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

Benefits offered by this job

Bonus pay

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Masimo, a Danaher operating company, seeks a Senior Medical Writer to develop CERs and PMS reports compliant with EU MDR. You will perform systematic literature searches, appraise evidence across regulatory and clinical domains, and collaborate with Regulatory, Clinical Research, and Marketing to support product portfolio communications.

This is an on-site role in Irvine, CA. Ideal candidates have experience authoring regulatory documents, strong literature management skills, and the ability to

Qualifications

• Experience conducting systematic literature reviews.
• Ability to summarize clinical information for technical and non-technical audiences.
• Experience managing literature search platforms.
• Strong organizational skills with documentation discipline.

Responsibilities

• Lead CERs and PMS reports development and updates per EU MDR and MEDDEV guidance.
• Design and execute systematic literature searches; maintain references.
• Critically appraise literature for quality and relevance to device claims.
• Interpret protocols and study results for evidence summaries.
• Prepare literature reviews, evidence summaries and benefit-risk assessments.
• Monitor evolving literature related to Masimo products and technologies.
• Contribute to clinical study reports and scientific manuscripts.

Skills

Literature reviews

Clinical appraisal

Regulatory knowledge

References 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 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.

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 of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus pay.

• Bonus / Incentive Pay 10% of annual base salary.
• Paid time off.
• Medical/dental/vision insurance.
• 401(k).

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

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.

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].

For more information, visit www.danaher.com.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.

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