Clinical Evaluation

This role predominantly focuses on writing, editing and reviewing regulatory (e.g., Clinical Evaluation Reports/clinical study reports/summaries/Summary of Safety and Clinical Performance / Periodic Safety Update Report etc.) documents and responses to Notified Bodies<br /> May write and edit manuscripts or abstracts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits and other projects requiring skill in medical communication.<br /> Collaborates with cross-functional team members daily, with the ability to provide solution orientated recommendations and to gather and analyze data related to the performance and safety of medical devices.<br /> Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.<br /> Continuously monitor and stay updated...