- Lead and support cross-functional projects in regulatory affairs and quality management.
 - Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.
 - Independently prepare submissions and change notifications for competent authorities and international agencies.
 - Update, and maintain technical documentation and dossiers for medical devices (Class I to III).
 - Collaborate with quality management in risk assessments, usability analyses, and post-market surveillance.
 - Maintain effective communication with global regulatory authorities, international partners, and internal teams.
 
Eine Stellenanzeige von Gynemed GmbH & Co. KG