Glyance is a small and growing medical aesthetics company developing and manufacturing high-quality dermal fillers. We operate strictly under ISO * and are preparing for CE certification. As a lean organization, we are looking for a hands-on contract Medical Writer who is comfortable working in a small team and taking real ownership of our CE submission clinical documentation.
This is a hands-on writing role with one clear goal: to prepare the clinical documentation needed to secure the CE Mark for our medical devices under the European Medical Device Regulation (EU MDR **). Engagement Terms Engagement type: contract (freelance or consultancy)

Working hours
synced to the Israel time zone

Location:
remote only Reporting line: Head of Clinical Affairs Position Overview The Medical Writer will be responsible for the clinical evaluation and the clinical documentation of the CE submission. Establishing the State of the Art (SOTA) and writing a submission-ready Clinical Evaluation Report (CER) is the central part of the role.

Key Responsibilities

Authoring, updating, and maintaining the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in line with EU MDR ** and MEDDEV 2.7/1 rev. 4 Establishing and documenting the State of the Art (SOTA):



systematic literature searches and reviews, and analysis of alternative treatments and benchmark devices Drafting the Acceptance Criteria (AC): defining and justifying measurable safety and performance acceptance criteria derived from the SOTA, against which the clinical data and the vantaggi-risk profile of the device are assessed Evaluating clinical evidence from clinical investigations, scientific literature, post-market surveillance, and risk management to demonstrate device safety and performance against the SOTA Writing the Summary of Safety and Clinical Performance (SSCP) Reviewing supporting documents, including the instructions for use and the risk management file, for consistency with the clinical evaluation Requirements At least 5 years of experience in medical writing for medical devices, including CERs and SOTA reviews under the EU MDR Working knowledge of MDR **, MEDDEV 2.7/1 rev. 4, MDCG guidance, ISO *, ISO *, and ISO **
* Strong scientific writing in English, with attention to detail and data consistency Experience with Class III devices, dermal fillers, or aesthetic injectables – an advantage

📌 Freelance Medical Writer (Italia)
🏢 Glyance
📍 Italia