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
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.
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.
Partner with regulatory affairs and medical experts to ensure accurate and timely submission of PSURs to regulatory authorities.
Continuously monitor and stay updated with evolving safety re...