EU MDR Clinical Writer & CER Expert

Argon Medical Devices Inc; Plano (TX); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Argon Medical Devices Inc in Plano, TX seeks an EU MDR Clinical Writer to support all EU MDR Technical Documentation. You will interpret clinical and non‑clinical data for CEPs, CERs, PMCF Plans and Reports, and contribute to regulatory submissions while coordinating with Regulatory, R&D, and Quality teams.

The role requires expert clinical documentation under EU MDR, strong literature review capabilities, and proficiency with ISO standards.

Qualifikationen

• Bachelor’s degree in sciences or medical writing; advanced degree preferred.
• Minimum 3 years authoring CERs and related clinical documentation under EU MDR; 5+ years preferred.
• Experience responding to clinical deficiencies or Notified Body questions is preferred.
• Experience in regulated medical device industry and PMCF strategy development.

Aufgaben

• Develop and maintain Clinical Evaluation Plans and Reports per EU MDR and MDCG guidance.
• Develop PMCF Plans and Reports in line with EU MDR requirements.
• Serve as the clinical documentation SME for assigned product families.
• Conduct state-of-the-art literature reviews to support CERs.
• Coordinate with Regulatory, R&D, PMS, and Quality to gather required information.
• Ensure documentation aligns with ISO 13485/14155/14971 standards.
• Provide responses to clinical questions from Notified Bodies.
• Contribute to regulatory submissions, risk management files, SSCPs, and IFUs.
• Perform gap analyses and revise CERs for legacy products.
• Generate timelines and ensure on-time delivery; develop templates or SOPs as needed.
• Lead routine literature reviews for post-market surveillance.
• Organize references, graphics, tables for large technical documents.
• Independently write and edit scientifically complex documents.

Kenntnisse

CER authoring

EU MDR knowledge

Regulatory writing

Systematic literature reviews

Regulatory submissions support

Ausbildung

Bachelor's degree in sciences or medical writing

Advanced degree preferred

Tools

MS Word

MS Excel

PowerPoint

Jobbeschreibung

Argon Medical Devices Inc in Plano, TX seeks an EU MDR Clinical Writer to support all EU MDR Technical Documentation. You will interpret clinical and non‑clinical data for CEPs, CERs, PMCF Plans and Reports, and contribute to regulatory submissions while coordinating with Regulatory, R&D, and Quality teams.

The role requires expert clinical documentation under EU MDR, strong literature review capabilities, and proficiency with ISO standards.