The
Senior Medical Writer is responsible for the development of clinical evaluation reports (CERs) and post-market surveillance (PMS) reports in compliance with EU MDR and global regulatory standards. This role conducts systematic literature searches, appraises scientific evidence, and collaborates cross-functionally across Scientific Affairs, Clinical Research, Regulatory Affairs, Engineering, and Marketing to support product portfolio compliance and clinical communications.
This position reports to the
Sr Director, Scientific Affairs & Research and is part of Medical Affairs located in Irvine, CA and will be an on-site role.
In this role, you will have the opportunity to:• Lead the development, maintenance, and periodic updates of CERs and PMS evaluation summaries in accordance with EU MDR, MEDDEV 2.7/1 Rev. 4 and global regulatory guidance.
• Design, execute, and document systematic literature searches and screening strategies, while maintaining scientific reference libraries and ensure accurate citation and documentation of supporting evidence.
• Critically appraise scientific literature for quality, clinical relevance, and alignment with intended device claims.
• Interpret clinical study protocols, statistical analysis plans, and study results to incorporate into clinical evidence summaries.
• Prepare literature review reports, evidence summaries, state-of-the-art analyses, clinical data appraisals, and benefit-risk assessments,
• Monitor emerging scientific literature and technological developments relevant to Masimo products, therapeutic areas, and competitive technologies.
• Contribute to clinical study reports, white papers, conference abstracts, posters and scientific manuscripts for peer-reviewed journals
The essential requirements of the job include:• Demonstrated experience conducting systematic literature reviews and critical appraisals of scientific literature.
• Proven 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.
It would be a plus if you also possess previous experience in:- Direct experience 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 documents.
- Proven track record of scientific publication in peer-reviewed journals
Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.
The annual salary range for this role is $130,000-$150,000 This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
Bonus / Incentive Pay 10% of annual base salary
This job is also eligible for bonus / incentive pay. This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions.
