Remote Medical Writer for EU MDR CE Submissions

Glyance; Italia; Remoto; EUR 83.000 - 96.000; Part-time

Descrizione del lavoro

Glyance is a small and growing medical aesthetics company developing and manufacturing high‑quality dermal fillers, pursuing EU MDR CE certification. We seek a hands‑on contract Medical Writer to own the CE submission clinical documentation and ensure a robust CER and SOTA deliverable.

The role focuses on State of the Art establishment, CE submission readiness, and coordinating with the Head of Clinical Affairs in a remote, contract setting.

Competenze

• 5+ years of medical writing experience for medical devices.
• Experience with CERs and SOTA reviews under EU MDR.
• Strong scientific writing in English with attention to detail.

Mansioni

• Authoring CEP and CER in line with EU MDR 2017/745 and MEDDEV 2.7/1 rev. 4.
• Establishing and documenting SOTA through literature searches and benchmark devices.
• Drafting acceptance criteria based on SOTA for safety and performance.
• Evaluating clinical evidence from investigations, literature, and post‑market data.
• Writing the Summary of Safety and Clinical Performance (SSCP).
• Reviewing IFU and risk management to ensure consistency with the clinical evaluation.

Conoscenze

Medical writing

EU MDR

CERs

SOTA reviews

Clinical documentation

Descrizione del lavoro

Glyance is a small and growing medical aesthetics company developing and manufacturing high‑quality dermal fillers, pursuing EU MDR CE certification. We seek a hands‑on contract Medical Writer to own the CE submission clinical documentation and ensure a robust CER and SOTA deliverable.

The role focuses on State of the Art establishment, CE submission readiness, and coordinating with the Head of Clinical Affairs in a remote, contract setting.