Freelance Medical Writer – EU MDR CE Submission; SOTA, CEP, CER

Position: Freelance Medical Writer – EU MDR CE Submission (SOTA, CEP, CER)
Glyance is a small and growing medical aesthetics company developing and manufacturing high-quality dermal fillers. We operate strictly under ISO 13485 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 2017/745).

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 2017/745 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 benefit-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 2017/745, MEDDEV 2.7/1 rev. 4, MDCG guidance, ISO 13485, ISO 14155, and ISO 14971
Strong scientific writing in English, with attention to detail and data consistency

Experience with Class III devices, dermal fillers, or aesthetic injectables – an advantage