Senior Medical Writer (Medical Devices)

Location: On-site in Irvine, California, United States

Annual salary: $130,000–$150,000, plus eligibility for a 10% annual base salary bonus.

Company

Masimo is a hirify.global operating company developing medical monitoring technologies, sensors, patient monitors, and automation and connectivity solutions.

What you will do

• Lead the development, maintenance, and periodic updates of clinical evaluation reports and post-market surveillance evaluation summaries.
• Design, execute, and document systematic literature searches and screening strategies.
• Critically appraise scientific literature for quality, clinical relevance, and alignment with intended device claims.
• Interpret clinical study protocols, statistical analysis plans, and study results for clinical evidence summaries.
• Prepare literature reviews, evidence summaries, state-of-the-art analyses, clinical data appraisals, and benefit-risk assessments.
• Contribute to clinical study reports, white papers, conference abstracts, posters, and peer-reviewed scientific manuscripts.

Requirements

• Demonstrated experience conducting systematic literature reviews and critical appraisals of scientific literature.
• 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.
• Ability to work on-site in Irvine, California, United States.

Nice to have

• Experience authoring EU MDR-compliant clinical evaluation reports and post-market surveillance reports for medical devices.
• Working knowledge of EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 14155, and FDA clinical guidance documents.
• Scientific publications in peer-reviewed journals.

Culture & Benefits

• Paid time off.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility for bonus and incentive pay.