Job Description

JOB DESCRIPTION At Criterion Edge, we’re committed to empowering companies to deliver better healthcare solutions. By leveraging best-in-class writing processes, technology and expertise, we empower healthcare companies to achieve their global regulatory goals with superior quality, speed flexibility, and budget control. Be on the leading edge by applying your regulatory writing expertise to a variety of regulatory writing projects with top industry clients.

Criterion Edge (CE) is seeking a remote contractor for the Clinical Evaluation Report (CER) Regulatory Writer role. The position is responsible for providing regulatory writing expertise for the development of initial and annual update CERs that support the overall global regulatory submission requirements for the client’s portfolio of medical device products.

PLEASE NOTE THAT PREVIOUS CER WRITING EXPERIENCE IS REQUIRED FOR THIS ROLE.

SPECIFIC RESPONSIBILITIES INCLUDE:

• Prepare regulatory documents and responses to regulatory authorities, specifically working on Clinical Evaluation Reports (CERs)
• Combine understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.
• Perform routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical devices
• Perform critical review and data analysis from clinical investigations and literature for incorporation into the CER
• Serve as the regulatory writer on assigned CER projects, collaborating with the CE Scientific Quality Manager to meet all project deliverable timelines
• Ensure documents are produced in accordance with procedures, internal and external guidelines, and electronic templates

REQUIRED EXPERIENCE:

• PREVIOUS EXPERIENCE WRITING CERS AND RELATED DOCUMENTS IN ACCORDANCE WITH MEDDEV 2.7/1 REV 3 AND 4
• Effective written, verbal and presentation skills in the area of technical/clinical applications
• Strong command of medical and surgical terminology
• Demonstrated ability to identify and adapt to shifting priorities and competing demands
• Proficiency in document development and management using Word, Excel, PowerPoint and EndNote
• Training and degree in science, engineering, or medical fields. Scientific/research background (i.e., understands research design, methodology, and statistics)

If interested, please submit a resume/CV and a cover letter. PLEASE NOTE THAT PREVIOUS CER WRITING EXPERIENCE IS REQUIRED FOR THIS ROLE.

For more job openings, check out https://criterionedge.com/careers/

Job Types: Part-time, Contract

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