Job Description

Masimo seeks a Senior Medical Writer to develop clinical evaluation and post-market surveillance reports for medical devices under EU MDR and global regulatory standards. The role involves systematic literature reviews, scientific evidence appraisal, and cross-functional collaboration to support product compliance and clinical communications.

Responsibilities

• Lead development, maintenance, and periodic updates of clinical evaluation reports per EU MDR requirements
• Design and execute systematic literature searches while maintaining scientific reference libraries
• Critically appraise scientific literature for quality, relevance, and alignment with device claims
• Prepare evidence summaries, benefit-risk assessments, and state-of-the-art analyses
• Monitor emerging scientific literature and contribute to clinical study reports, manuscripts, and conference presentations

Requirements

• Demonstrated experience conducting systematic literature reviews and critical appraisals
• Ability to interpret and communicate complex clinical information to diverse audiences
• Experience managing scientific references and literature search platforms
• Strong organizational skills and reference management software proficiency
• Direct authoring experience with EU MDR-compliant CERs and PMS reports (preferred)
• Knowledge of EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 14155, and FDA guidance (preferred)
• Track record of peer-reviewed scientific publications (preferred)

Compensation: $130,000-$150,000 base; eligible for 10% annual bonus

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