Senior Medical Writer

Responsibilities

• Lead development and periodic updates of CERs and PMS evaluation summaries under EU MDR and MEDDEV 2.7/1 Rev. 4

• Design and document systematic literature searches and screening strategies

• Critically appraise scientific literature for quality and clinical relevance

• Interpret clinical study protocols, statistical plans and results into evidence summaries

• Prepare literature reviews, state-of-the-art analyses and benefit-risk assessments

• Monitor emerging literature and technology relevant to Masimo products

• Contribute to clinical study reports, white papers, abstracts and manuscripts

Requirements

• Experience conducting systematic literature reviews and critical appraisals

• Ability to summarize complex clinical information for varied audiences

• Experience managing scientific references and literature search platforms

• Strong organizational skills and reference management software experience

Preferred Qualifications

• Authoring EU MDR-compliant CERs and PMS reports for medical devices

• Working knowledge of EU MDR, MEDDEV 2.7/1 Rev. 4, ISO 14155 and FDA clinical guidance

• Peer-reviewed scientific publication record

Benefits

• Paid time off, medical, dental and vision insurance, 401(k)

• Bonus / incentive pay eligibility, target 10% of annual base salary

About the Company

• Masimo is a global medical technology company and a Danaher operating company developing non-invasive monitoring technologies.