Senior Medical Writer: CERs & PMS for EU MDR (On-Site Irvine)

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

Benefits offered by this job

Bonus pay

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Masimo, a Danaher operating company, seeks a Senior Medical Writer to develop CERs and PMS reports compliant with EU MDR. You will perform systematic literature searches, appraise evidence across regulatory and clinical domains, and collaborate with Regulatory, Clinical Research, and Marketing to support product portfolio communications.

This is an on-site role in Irvine, CA. Ideal candidates have experience authoring regulatory documents, strong literature management skills, and the ability to

Qualifications

• Experience conducting systematic literature reviews.
• Ability to summarize clinical information for technical and non-technical audiences.
• Experience managing literature search platforms.
• Strong organizational skills with documentation discipline.

Responsibilities

• Lead CERs and PMS reports development and updates per EU MDR and MEDDEV guidance.
• Design and execute systematic literature searches; maintain references.
• Critically appraise literature for quality and relevance to device claims.
• Interpret protocols and study results for evidence summaries.
• Prepare literature reviews, evidence summaries and benefit-risk assessments.
• Monitor evolving literature related to Masimo products and technologies.
• Contribute to clinical study reports and scientific manuscripts.

Skills

Literature reviews

Clinical appraisal

Regulatory knowledge

References management

Tools

Reference management software

Job description

Masimo, a Danaher operating company, seeks a Senior Medical Writer to develop CERs and PMS reports compliant with EU MDR. You will perform systematic literature searches, appraise evidence across regulatory and clinical domains, and collaborate with Regulatory, Clinical Research, and Marketing to support product portfolio communications.

This is an on-site role in Irvine, CA. Ideal candidates have experience authoring regulatory documents, strong literature management skills, and the ability to