Clinical Medical Writer

Argon Medical Devices Inc•Plano, TX

10h

About The Position

The EU MDR Clinical Writer serves as the primary clinical writer supporting Argon Medical Devices’ EU MDR Technical Documentation. The role provides clinical support for formal Technical Documentation reviews conducted by the European Notified Body, as well as documentation files that do not require formal review for certification. It requires interpreting and analyzing clinical and non-clinical data for scientific communication projects, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), systematic literature reviews, Post Market Clinical Follow-Up (PMCF) Plans, and PMCF Reports. The Clinical Medical Writer works across Regulatory, R&D, Post-Market Experience, and Quality teams to obtain relevant information and produce clear, scientifically rigorous documentation. The role also contributes to regulatory submissions, risk management files, SSCPs, IFUs, and post-market surveillance activities, while maintaining knowledge of relevant standards, regulations, and technologies.

Requirements

Bachelor’s degree in the sciences, a medical-related field, or medical/technical writing.
At least 3 years of experience authoring CERs and related clinical documentation under EU MDR.
Experience in the regulated medical device industry.
Experience developing PMCF strategies, PMCF Plans, and PMCF Reports.
Understanding of European clinical requirements, including EU MDR, applicable MDCG documents, and MEDDEV 2.7.1.
Understanding of current regulatory and clinical requirements governing medical devices, including EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, ISO 14971, ISO 14155, and ISO 13485.
Proven experience writing clinical technical documentation under EU MDR and managing documentation through the Notified Body review process.
Knowledge of narrative and systematic literature reviews.
Excellent understanding of scientific or clinical research and methods.
Proficiency in MS Outlook, Word, Excel, and PowerPoint.

Nice To Haves

Advanced degree in the sciences, a medical-related field, or medical/technical writing preferred.
Five or more years of experience authoring CERs and related clinical documentation under EU MDR preferred.
Experience responding to clinical deficiencies, nonconformities, or questions from Notified Bodies is strongly preferred.

Responsibilities

Develop and maintain Clinical Evaluation Plans and Reports in compliance with EU MDR, MEDDEV 2.7.1 Rev. 4, and applicable MDCG documents.
Develop and maintain PMCF Plans and Reports in compliance with EU MDR and applicable guidance and MDCG documents.
Serve as the clinical documentation subject matter expert for assigned product families.
Conduct State of the Art literature reviews and analyses to support CERs in accordance with EU MDR requirements.
Conduct systematic literature reviews and analyze clinical data from sources including clinical trials, PMS, and PMCF.
Coordinate with Regulatory, R&D, Post-Market Experience, and Quality to access and identify necessary preclinical, clinical, and technical information.
Ensure documentation aligns with ISO standards, including ISO 13485, ISO 14155, and ISO 14971.
Provide and manage responses to clinical questions raised by the EU MDR Notified Body.
Ensure clinical documentation clearly aligns with risk management files.
Contribute to regulatory submissions, risk management files, SSCPs, and IFUs.
Ensure Clinical Evaluations are performed in accordance with internal procedures.
Perform gap analyses and revise existing CERs for legacy products against the EU Medical Device Regulation.
Generate and track timelines, follow through on tasks, and ensure quality results.
Develop or revise templates, SOPs, or guidelines for regulatory, medical, or clinical documents as needed.
Participate in post-market surveillance by leading routine systematic literature reviews, including screening articles against inclusion and exclusion criteria, extracting data, interpreting study results, synthesizing literature, and preparing formal report summaries.
Organize and incorporate references, graphics, tables, and data listings into large technical documents.
Independently write and edit scientifically complex documents with substantial intellectual content.
Maintain knowledge of current internal and external standards, regulations, and technologies related to the function.