Argon Medical Devices, Inc. is hiring : Clinical Medical Writer in Plano

Argon Medical Devices is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures.

The EU MDR Clinical Writer serves as the primary clinical writer to support all EU MDR Technical Documentation. The position provides clinical support for all formal Technical Documentation reviews conducted by the European Notified Body as well as Technical Documentation for files that do not require formal review for certification.

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 Post Market Clinical Follow-Up (PMCF) Plans and Reports in compliance with EU MDR and applicable guidance / MDCG documents.
• Generate State of the Art (SOA) Plans and Reports to support the CER per EU MDR.
• Conduct systematic literature reviews and analyze clinical data from various sources including clinical trials, post-market surveillance (PMS), and post-market clinical follow-up (PMCF).
• Coordinate with various departments to access and identify the necessary preclinical, clinical and technical information.
• Ensure documentation aligns with ISO standards (e.g., ISO 13485, ISO 14155, 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.
• Perform gap analyses and revise existing CERs for legacy products against the EU Medical Device Regulation.

Requirements :

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