Job Description

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. Our values describe what we believe in and how we operate. These values are our moral compass which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

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. The ability to interpret and analyze clinical and non-clinical data pertinent to scientific communication projects (e.g. Clinical Evaluation Plans and Reports, literature reviews, and post-market clinical summaries) is required.

• 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 (e.g., Regulatory, R&D, Post-Market Experience, and Quality) 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.
• 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. Follows through on all tasks and ensures quality results.
• May develop or revise templates, SOPs, or guidelines for regulatory/medical/clinical documents.
• Participates in post-market surveillance activities by leading 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 device groups or sub-groups.
• Organizes and incorporates information, such as references, graphics, tables, and data listings for the creation of large, technical documents.
• Independently, critically writes and edits scientifically complex documents for substantial intellectual content.
• Maintains knowledge of current internal and external standards, regulations and technologies related to this function.
• Other duties as assigned.

• Bachelor’s degree (advanced degree preferred) in the sciences, a medical-related field, or medical/technical writing required.
• Understanding of European clinical requirements, including EU MDR, applicable MDCG documents, and MEDDEV 2.7.1 is required.
• 3+ years of experience in regulated medical device industry required.
• Proven experience writing CERs (and associated clinical documents) under EU MDR and managing the documentation through the Notified Body review process is required.
• Knowledge in narrative and systematic literature reviews required.
• Understanding of current regulatory and clinical requirements governing medical devices, including but not limited to - EU MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485 required.

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