Senior Medical Writer

Danaher•Irvine, CA

5d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

Responsibilities

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