EU MDR Clinical Writer: CER & PMCF Expert

Argon Medical Devices, Inc.; Plano (TX); On-site; USD 95,000 - 135,000; Full time

Job summary

Argon Medical Devices, Inc. is seeking an EU MDR Clinical Writer to support clinical documentation for regulatory submissions and Notified Body reviews. The role focuses on CERs, PMCF plans and reports, and critical analyses of clinical data across product families.

You will collaborate across Regulatory, R&D, Post‑Market Experience, and Quality to ensure ISO alignment and timely responses to regulatory questions, with a strong emphasis on robust scientific communication.

Qualifications

• Bachelor’s degree in sciences or medical/technical writing is required.
• Minimum 3 years of experience authoring CERs and clinical documentation under EU MDR; 5+ years preferred.
• Experience responding to clinical deficiencies, nonconformities, or questions from Notified Bodies is preferred.
• Experience in regulated medical device industry.
• Understanding of EU MDR, MDCG documents, and MEDDEV 2.7.1 is required.
• Proficiency in MS Outlook, Word, Excel and PowerPoint.

Responsibilities

• Develop and maintain Clinical Evaluation Plans and CERs in compliance with EU MDR, MEDDEV 2.7.1 Rev. 4.
• Develop and maintain PMCF Plans and Reports in compliance with EU MDR guidance.
• Serve as the clinical documentation subject matter expert for assigned product families.
• Conduct State of the Art literature reviews and analyses for CERs.
• Conduct systematic literature reviews and analyze clinical data from trials and PMCF.
• Coordinate with Regulatory, R&D, Post‑Market Experience, and Quality teams to gather information.
• Ensure documentation aligns with ISO 13485, ISO 14155, ISO 14971.
• Provide responses to clinical questions raised by Notified Body.
• Contribute to risk management files, SSCPs, and IFUs.
• Perform gap analyses and revise CERs for legacy products.
• Generate and track timelines; maintain quality of deliverables.
• May develop or revise templates, SOPs, or guidelines for regulatory/medical/clinical documents.
• Lead routine systematic literature reviews for post‑market surveillance groups.

Skills

CER writing

EU MDR

Regulatory writing

PMCF planning

SOTA literature

Scientific writing

Project coordination

Education

Bachelor's degree in sciences or medical/technical writing

Advanced degree preferred

Tools

MS Outlook

Word

Excel

PowerPoint

Job description

Argon Medical Devices, Inc. is seeking an EU MDR Clinical Writer to support clinical documentation for regulatory submissions and Notified Body reviews. The role focuses on CERs, PMCF plans and reports, and critical analyses of clinical data across product families.

You will collaborate across Regulatory, R&D, Post‑Market Experience, and Quality to ensure ISO alignment and timely responses to regulatory questions, with a strong emphasis on robust scientific communication.