Senior Medical Writer — CERs, PMS & Regulatory Reports

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

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.