Senior Medical Writer — Clinical Evidence & CERs (EU MDR)

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

Job summary

Masimo, a Danaher operating company, in Irvine, CA, seeks a Senior Medical Writer to develop CERs and PMS reports for EU MDR and global regulatory standards. You will design literature searches, appraise evidence, and collaborate across Scientific Affairs, Clinical Research, Regulatory Affairs, Engineering and Marketing.

You will interpret study protocols and results to support clinical communications, contribute to clinical study reports and peer-reviewed manuscripts, monitor emerging

Qualifications

• Experience conducting systematic literature reviews and critical appraisals of scientific literature.
• 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 development, maintenance, and updates of CERs and PMS reports per EU MDR and MEDDEV guidance.
• Design, execute, and document systematic literature searches and screening strategies.
• Critically appraise literature for quality, relevance, and alignment with device claims.
• Interpret clinical study protocols and results for clinical evidence summaries.
• Prepare literature review reports, evidence summaries, and state-of-the-art analyses.
• Monitor emerging literature and developments relevant to Masimo products.

Skills

Systematic literature reviews

Interpret complex clinical information

Literature appraisal

Reference management software

Tools

Reference management software

Job description

Masimo, a Danaher operating company, in Irvine, CA, seeks a Senior Medical Writer to develop CERs and PMS reports for EU MDR and global regulatory standards. You will design literature searches, appraise evidence, and collaborate across Scientific Affairs, Clinical Research, Regulatory Affairs, Engineering and Marketing.

You will interpret study protocols and results to support clinical communications, contribute to clinical study reports and peer-reviewed manuscripts, monitor emerging